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FDA 510(k), K161672, SpeediCath Flex Coude
FDA 510(k), K161672, SpeediCath Flex Coude
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$149.00 USD
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510(K) Number: K161672
Device Name: SpeediCath Flex Coude
Manufacturer: Coloplast Corp.
Device Classification Name: catheter, urethral
Regulation Number: 876.5130
Classification Product Code: GBM
Date Received: 06/09/2016
Decision Date: 09/29/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SpeediCath Flex Coude
Manufacturer: Coloplast Corp.
Device Classification Name: catheter, urethral
Regulation Number: 876.5130
Classification Product Code: GBM
Date Received: 06/09/2016
Decision Date: 09/29/2016
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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