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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom With Nonoxynol-9
510(k) Number K970791
Device Name INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY
Applicant
Custom Services Intl., Inc.
3111 W. Post Rd.
Las Vegas,  NV  89118
Applicant Contact LILLIE C THOMAS
Correspondent
Custom Services Intl., Inc.
3111 W. Post Rd.
Las Vegas,  NV  89118
Correspondent Contact LILLIE C THOMAS
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received03/04/1997
Decision Date 06/03/1997
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
Predetermined Change
Control Plan Authorized		 No
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