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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 K874921
Device Name HEADFIRST (CONDOM)
Applicant
STUAL PRODUCTS, INC.
P.O. BOX 524
LINDENHURST,  NY  11757
Applicant Contact JAMES SCHISGALL
Correspondent
STUAL PRODUCTS, INC.
P.O. BOX 524
LINDENHURST,  NY  11757
Correspondent Contact JAMES SCHISGALL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/03/1987
Decision Date 05/13/1988
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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