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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 K901416
Device Name CONDOM (RUBBER) CONTRACEPTIVE
Applicant
Aladan Corp.
630 Columbia Hwy.
Box 8308
Dothan,  AL  36304
Applicant Contact BRADLEY PUGH
Correspondent
Aladan Corp.
630 Columbia Hwy.
Box 8308
Dothan,  AL  36304
Correspondent Contact BRADLEY PUGH
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/26/1990
Decision Date 06/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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