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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Gastro-Urology
510(k) Number K874493
Device Name BELLA - VAC IRRIGATOR
Applicant
Bel-Can Industries
775 Bloomfield Ave.
Montclair,  NJ  07042
Applicant Contact ELSA CANNELLA
Correspondent
Bel-Can Industries
775 Bloomfield Ave.
Montclair,  NJ  07042
Correspondent Contact ELSA CANNELLA
Regulation Number876.4370
Classification Product Code
KQT  
Date Received11/02/1987
Decision Date 02/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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