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FDA 510(k), K202285, Medline ENfit OTC Feeding Syringe
FDA 510(k), K202285, Medline ENfit OTC Feeding Syringe
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510(K) Number: K202285
Device Name: Medline ENfit OTC Feeding Syringe
Manufacturer: Medline Industries, Inc.
Device Classification Name: enteral syringes with enteral specific connectors
Regulation Number: 876.5980
Classification Product Code: PNR
Date Received: 08/12/2020
Decision Date: 10/09/2020
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Medline ENfit OTC Feeding Syringe
Manufacturer: Medline Industries, Inc.
Device Classification Name: enteral syringes with enteral specific connectors
Regulation Number: 876.5980
Classification Product Code: PNR
Date Received: 08/12/2020
Decision Date: 10/09/2020
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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