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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 K910284
Device Name CONDOMS (RUBBER CONTRACEPTIVES)
Applicant
SURETEX, LTD.
C/O G. PREMJEE (U.S.A.), INC.
P.O. BOX 1084
AVONDALE,  AZ  85323
Applicant Contact ANIL UTAMCHANDANI
Correspondent
SURETEX, LTD.
C/O G. PREMJEE (U.S.A.), INC.
P.O. BOX 1084
AVONDALE,  AZ  85323
Correspondent Contact ANIL UTAMCHANDANI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/23/1991
Decision Date 06/04/1991
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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