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Date Received: 01/30/2020: Decision Date: 02/19/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology Consultations listed on these pages are the subjects of a voluntary premarket engagement between FDA and the developer of the new plant variety under FDA’s 1992 Statement of Policy: Foods Derived from New Plant Varieties. FootDocPreneur, LLC Business Trade Names: (1) Zoom Laser International LLC (2) Zuckerman Future Technologies LLC 1803 Country Club Drive Cherry Hill, NJ 08003 Registration Number: 3015529593 FEI Number*: 3015529593 Status: Active Initial Distributor/Importer: Yes WARNING LETTER. : 125418 Approval Date: 08/03/2012. From approving medicin Pragmatic Compliance LLC, Ocala, Florida. 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Basic concepts that should be employed by everyone regulated by the FDA – review of quarterly quality topics to keep current; Device Classification Name: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples: 510(k) Number: K230675: Device Name Date Received: 12/07/2018: Decision Date: 04/17/2019: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel Date Received: 07/21/2021: Decision Date: 06/02/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel Device: Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-Generic Name: Automated external defibrillators (non-wearable) Nemko USA Inc. 50 x 30mm (5883); Ringer perfusion balloon catheter, 3. 50 x 20mm (5882); Ringer perfusion balloon catheter, 2. Re: 667431. Re: 696281. § 352 Oct 24, 2024 · Acne . 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Make sure to check out the recall list at Food Safety Basics, LLC (www. , LLC Application No. Regulation Medical Specialty: General Hospital: Review Panel: General & Plastic Surgery : Product Code Date Received: 09/07/2018: Decision Date: 01/17/2019: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel Dec 23, 2024 · Device: Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-Generic Name: Automated external defibrillators (non-wearable) Jan 6, 2025 · Device: monitor, breathing frequency: Regulation Description: Breathing frequency monitor. FDA Facility Fee – Annual fee for each facility involved in the ANDA. December 12, 2024. Date of experience: August 02, 2019. Jerry Doane. 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Date Received: 10/13/2020: Decision Date: 02/09/2021: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology 510k Review Panel John Jenkins is Director of the Office of New Drugs at the Center for Drug Evaluation and Research. Phone Email. TEDA Biopharm Research, #5, 4th Street, TEDA: Tianjin, CN 300457 Jan 6, 2025 · (1) Cardinal Health 200 LLC (2) Formerly known as Covidien (3) Formerly known as Kendall, a Division of Tyco Healthcare Group LP 1222 SHERWOOD RD. 4270: Applicant Zyno Medical LLC 177 Pine St Natick MA 01760-1331: For Additional Information Contact: 508-650-2008: Manufacturer Reason for Recall: There is a defect in the air-in-line software algorithm. The pricing was competitive. 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