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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 K896142
Device Name RUBBER CONTRACEPTIVE (CONDOM)
Applicant
GUANGZHOU NO. 11 RUBBER FACTORY
199 N. EL CAMINO REAL
F-286
ENCINITAS,  CA  92024
Applicant Contact MARK S ROBINSON
Correspondent
GUANGZHOU NO. 11 RUBBER FACTORY
199 N. EL CAMINO REAL
F-286
ENCINITAS,  CA  92024
Correspondent Contact MARK S ROBINSON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/24/1989
Decision Date 06/06/1990
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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