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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 K840268
Device Name IRRIGATION SYSTEM
Applicant
COLOPLAST A/S
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COLOPLAST A/S
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5895
Classification Product Code
EXD  
Date Received01/23/1984
Decision Date 04/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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