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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 K790749
Device Name COLOSTOMY ENEMA DEVICE
Applicant
Vabar Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vabar Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5895
Classification Product Code
EXD  
Date Received04/17/1979
Decision Date 05/16/1979
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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