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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 K970767
Device Name CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
Applicant
CUSTOM SERVICES INTL., INC.
3111 WEST POST RD.
LAS VEGAS,  NV  89118
Applicant Contact LILLIE C THOMAS
Correspondent
CUSTOM SERVICES INTL., INC.
3111 WEST POST RD.
LAS VEGAS,  NV  89118
Correspondent Contact LILLIE C THOMAS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/03/1997
Decision Date 06/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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