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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 K880202
Device Name OKAMOTO CONDOMS
Applicant
Schmid Laboratories, Inc.
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Applicant Contact WAYNE H MATELSKI
Correspondent
Schmid Laboratories, Inc.
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Correspondent Contact WAYNE H MATELSKI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/19/1988
Decision Date 02/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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