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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 K874718
Device Name STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)
Applicant
SCHMID LABORATORIES, INC.
WASHINGTON SQUARE
1050 CONNECTICUT AVENUE, N.W.
washington,  DC  20036
Applicant Contact wayne h matelski
Correspondent
SCHMID LABORATORIES, INC.
WASHINGTON SQUARE
1050 CONNECTICUT AVENUE, N.W.
washington,  DC  20036
Correspondent Contact wayne h matelski
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/17/1987
Decision Date 12/08/1987
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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