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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K112860
FOIA Releasable 510(k) K112860
Device Name PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Applicant Contact BRIAN SCHMIDT
Correspondent
COLOPLAST A/S
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Correspondent Contact BRIAN SCHMIDT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/30/2011
Decision Date 06/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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