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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 K972428
Device Name EXTRAWEAR, GENTLEMEN'S CHOICE
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 Received06/27/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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