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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 K083770
Device Name COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
Applicant
COLOPLAST A/S
1525 WEST RIVER ROAD
MINNEAPOLIS,  MN  55411
Applicant Contact JANELL A COLLEY
Correspondent
COLOPLAST A/S
1525 WEST RIVER ROAD
MINNEAPOLIS,  MN  55411
Correspondent Contact JANELL A COLLEY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/18/2008
Decision Date 11/23/2009
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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