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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 K900358
Device Name SAXON WET LUBE
Applicant
SAFETEX CORP.
16101 CONTINENTAL BLVD.
COLONIAL HEIGHTS,  VA  23834
Applicant Contact RONALD L DAVIS
Correspondent
SAFETEX CORP.
16101 CONTINENTAL BLVD.
COLONIAL HEIGHTS,  VA  23834
Correspondent Contact RONALD L DAVIS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/25/1990
Decision Date 04/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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