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FDA 510(k), K160855, U&U Enteral Syringe
FDA 510(k), K160855, U&U Enteral Syringe
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510(K) Number: K160855
Device Name: U&U Enteral Syringe
Manufacturer: BLACK WANG
Device Classification Name: Enteral Syringes With Enteral Specific Connectors
Regulation Number: PNR
Classification Product Code: KXA
Date Received: 03/28/2016
Decision Date: 11/22/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: U&U Enteral Syringe
Manufacturer: BLACK WANG
Device Classification Name: Enteral Syringes With Enteral Specific Connectors
Regulation Number: PNR
Classification Product Code: KXA
Date Received: 03/28/2016
Decision Date: 11/22/2016
Decision: Substantially Equivalent (SESE)
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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