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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 K922889
Device Name CONDOOM SHELF LIFE -- MODIFICATIONS
Applicant
SAFETEX CORP.
16101 CONTINENTAL BLVD.
colonial heights,  VA  23834
Applicant Contact davis
Correspondent
SAFETEX CORP.
16101 CONTINENTAL BLVD.
colonial heights,  VA  23834
Correspondent Contact davis
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/22/1992
Decision Date 09/01/1993
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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