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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 K103254
FOIA Releasable 510(k) K103254
Device Name PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
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  
Subsequent Product Code
FCE  
Date Received11/03/2010
Decision Date 01/31/2011
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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