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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 K822088
Device Name MALE CONDOM
Applicant
SCHMID LABORATORIES, INC.
HAMEL, PARK, MCCABE AND SAUDER
888 SIXTEENTH STREET, N.W.
WASHINTON,  DC  20006
Applicant Contact WAYNE MATELSKI
Correspondent
SCHMID LABORATORIES, INC.
HAMEL, PARK, MCCABE AND SAUDER
888 SIXTEENTH STREET, N.W.
WASHINTON,  DC  20006
Correspondent Contact WAYNE MATELSKI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/13/1982
Decision Date 11/03/1982
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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