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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 K905279
Device Name CONDOM (RUBBER) CONTRACEPTIVE
Applicant
ALADAN CORP.
P.O. BOX 921548
NORCROSS,  GA  30092
Applicant Contact BRADLEY PUGH
Correspondent
ALADAN CORP.
P.O. BOX 921548
NORCROSS,  GA  30092
Correspondent Contact BRADLEY PUGH
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/23/1990
Decision Date 02/19/1991
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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