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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 K963319
Device Name OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
Applicant
CUSTOM SERVICES INTL., INC.
3111 WEST POST RD.
LAS VEGAS,  NV  89118
Applicant Contact LILLIE C THOMAS, M.S.
Correspondent
CUSTOM SERVICES INTL., INC.
3111 WEST POST RD.
LAS VEGAS,  NV  89118
Correspondent Contact LILLIE C THOMAS, M.S.
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/12/1996
Decision Date 01/22/1997
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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