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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K872619
Device Name PREVENTETTE (CONDOM)
Applicant
REB ENTERPRISES, INC.
P.O. BOX 307
JONESVILLE,  LA  71343 -0307
Applicant Contact ROBERT FIELD
Correspondent
REB ENTERPRISES, INC.
P.O. BOX 307
JONESVILLE,  LA  71343 -0307
Correspondent Contact ROBERT FIELD
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/06/1987
Decision Date 11/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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