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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name collector, ostomy
510(k) Number K830841
Device Name COLOSTOMY BAG
Applicant
C & D COLOSTOMY PAD CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
C & D COLOSTOMY PAD CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5900
Classification Product Code
EXB  
Date Received03/17/1983
Decision Date 07/19/1983
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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