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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 K792634
Device Name CONCEPTROL/THIN PROPHYLACTICS
Applicant
ORTHO PHARMACEUTICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ORTHO PHARMACEUTICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/19/1979
Decision Date 01/16/1980
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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