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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 K943933
Device Name SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
Applicant
Aladan Corp.
2926 Columbia Hwy.
P.O. Box 8308
Dothan,  AL  36304
Applicant Contact NEIL ANDERSON, RAC
Correspondent
Aladan Corp.
2926 Columbia Hwy.
P.O. Box 8308
Dothan,  AL  36304
Correspondent Contact NEIL ANDERSON, RAC
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/12/1994
Decision Date 06/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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