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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 K874791
Device Name CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)
Applicant
Schmid Laboratories, Inc.
Rte. 46 W.
Little Falls,  NJ  07424
Applicant Contact PHYLISS M BARBER
Correspondent
Schmid Laboratories, Inc.
Rte. 46 W.
Little Falls,  NJ  07424
Correspondent Contact PHYLISS M BARBER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/23/1987
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
Predetermined Change
Control Plan Authorized		 No
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