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FDA 510(k), K180070, SpeediCath Flex Coude Pro
FDA 510(k), K180070, SpeediCath Flex Coude Pro
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$149.00 USD
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$149.00 USD
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510(K) Number: K180070
Device Name: SpeediCath Flex Coude Pro
Manufacturer: Coloplast
Device Classification Name: catheter, urethral
Regulation Number: 876.5130
Classification Product Code: GBM
Date Received: 01/09/2018
Decision Date: 02/02/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SpeediCath Flex Coude Pro
Manufacturer: Coloplast
Device Classification Name: catheter, urethral
Regulation Number: 876.5130
Classification Product Code: GBM
Date Received: 01/09/2018
Decision Date: 02/02/2018
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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