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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
Applicant Contact ROBERT FIELD
Correspondent
Reb Enterprises, Inc.
P.O. Box 307
Jonesville,  LA  71343
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
Predetermined Change
Control Plan Authorized		 No
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