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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 K871267
Device Name BLAUSIEGEL TRANSPARENT CONDOMS
Applicant
TICOSAN, INC.
P.O. BOX 246
HARTSDALE,  NY  10530
Applicant Contact ELISABETH NIEDERMANN
Correspondent
TICOSAN, INC.
P.O. BOX 246
HARTSDALE,  NY  10530
Correspondent Contact ELISABETH NIEDERMANN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/31/1987
Decision Date 04/12/1988
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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