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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enema Kit
510(k) Number K904534
Device Name ENEMA BULB
Applicant
R.A.C., INC.
961 CHESTNUT STREET, S.W.
SUITE 107
GAINESVILLE,  GA  30501
Applicant Contact FLO BECKER
Correspondent
R.A.C., INC.
961 CHESTNUT STREET, S.W.
SUITE 107
GAINESVILLE,  GA  30501
Correspondent Contact FLO BECKER
Regulation Number876.5210
Classification Product Code
FCE  
Date Received10/04/1990
Decision Date 12/21/1990
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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