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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 K953813
Device Name LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
Applicant
London International U.S. Holdings, Inc.
1819 Main St., 8th Floor
P.O. Box 4703
Sarasota,  FL  34236
Applicant Contact PHYLISS M BARBER
Correspondent
London International U.S. Holdings, Inc.
1819 Main St., 8th Floor
P.O. Box 4703
Sarasota,  FL  34236
Correspondent Contact PHYLISS M BARBER
Regulation Number884.5310
Classification Product Code
LTZ  
Subsequent Product Code
HIS  
Date Received08/04/1995
Decision Date 07/22/1996
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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