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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 K897140
Device Name THIN CONDOM RAMSES & SHEIK
Applicant
SCHMID LABORATORIES, INC.
ROUTE 46 WEST
little falls,  NJ  07424
Applicant Contact phyliss m barber
Correspondent
SCHMID LABORATORIES, INC.
ROUTE 46 WEST
little falls,  NJ  07424
Correspondent Contact phyliss m barber
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/27/1989
Decision Date 07/13/1990
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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