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FDA 510(k), K140310, Peristeen Anal Irrigation System
FDA 510(k), K140310, Peristeen Anal Irrigation System
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510(K) Number: K140310
Device Name: Peristeen Anal Irrigation System
Manufacturer: COLOPLAST A/S
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 02/07/2014
Decision Date: 09/03/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Peristeen Anal Irrigation System
Manufacturer: COLOPLAST A/S
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 02/07/2014
Decision Date: 09/03/2015
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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