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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 K872736
Device Name PROPHYLACTIC (CONDOM)
Applicant
CIRCLE RUBBER CORP.
408 FRELINGHUYSEN AVE.
P.O. BOX 223
NEWARK,  NJ  07114
Applicant Contact MICKEY SAITO
Correspondent
CIRCLE RUBBER CORP.
408 FRELINGHUYSEN AVE.
P.O. BOX 223
NEWARK,  NJ  07114
Correspondent Contact MICKEY SAITO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/09/1987
Decision Date 10/20/1987
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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