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FDA 510(k), K090217, BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
FDA 510(k), K090217, BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
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510(K) Number: K090217
Device Name: BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
Manufacturer: COLOPLAST A/S
Device Classification Name: endoscopic injection needle, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FBK
Date Received: 01/29/2009
Decision Date: 04/23/2009
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
Manufacturer: COLOPLAST A/S
Device Classification Name: endoscopic injection needle, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FBK
Date Received: 01/29/2009
Decision Date: 04/23/2009
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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