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FDA 510(k), K150550, SilverCoat Silicone Foley Catheter
FDA 510(k), K150550, SilverCoat Silicone Foley Catheter
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$149.00 USD
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510(K) Number: K150550
Device Name: SilverCoat Silicone Foley Catheter
Manufacturer: COVALON TECHNOLOGIES, INC.
Device Classification Name: catheter, retention type, balloon
Regulation Number: 876.5130
Classification Product Code: EZL
Date Received: 03/03/2015
Decision Date: 11/24/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SilverCoat Silicone Foley Catheter
Manufacturer: COVALON TECHNOLOGIES, INC.
Device Classification Name: catheter, retention type, balloon
Regulation Number: 876.5130
Classification Product Code: EZL
Date Received: 03/03/2015
Decision Date: 11/24/2015
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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