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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 K880185
Device Name DUET (CONDOMS)
Applicant
AMERICAN LABORATORIES, INC.
25 HUTCHESON PLACE
LYNBROOK,  NY  11563
Applicant Contact JED FORMAN
Correspondent
AMERICAN LABORATORIES, INC.
25 HUTCHESON PLACE
LYNBROOK,  NY  11563
Correspondent Contact JED FORMAN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/15/1988
Decision Date 06/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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