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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name irrigator, ostomy
510(k) Number K121833
Device Name OSTOMY IRRIGATION SET
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS,  MN  55411
Applicant Contact TIM CRABTREE
Correspondent
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS,  MN  55411
Correspondent Contact TIM CRABTREE
Regulation Number876.5895
Classification Product Code
EXD  
Date Received06/22/2012
Decision Date 07/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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