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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K863870
Device Name GAUZE, NONABSORBABLE, NON-MEDICATED (INTERNAL)
Applicant
Med-Tex, Inc.
4770 N Lincoln Ave., Suite 14
Chicago,  IL  60625
Applicant Contact SHAN PADDA
Correspondent
Med-Tex, Inc.
4770 N Lincoln Ave., Suite 14
Chicago,  IL  60625
Correspondent Contact SHAN PADDA
Classification Product Code
EFQ  
Date Received10/03/1986
Decision Date 10/24/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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