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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 K140310
Device Name Peristeen Anal Irrigation System
Applicant
Coloplast A/S
1601 W. River Rd. N.
Minneapolis,  MN  55116
Applicant Contact MEG DANIEL
Correspondent
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact BRIAN SCHMIDT
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
FCE  
Date Received02/07/2014
Decision Date 09/03/2015
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
Predetermined Change
Control Plan Authorized		 No
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