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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 K943883
Device Name SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
Applicant
ALADAN CORP.
16101 CONTINENTAL BLVD.
COLONIAL HEIGHTS,  VA  23834
Applicant Contact RONALD DAVIS
Correspondent
ALADAN CORP.
16101 CONTINENTAL BLVD.
COLONIAL HEIGHTS,  VA  23834
Correspondent Contact RONALD DAVIS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/09/1994
Decision Date 04/14/1995
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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