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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K920399
Device Name COMPOUND BENZOIN TINCTURE USP FREPP
Applicant
Medi-Flex Hospital Products, Inc.
8717 W. 110th St., Suite 750
Overland Park,  KS  66210
Applicant Contact ORLANDO CORDOVA
Correspondent
Medi-Flex Hospital Products, Inc.
8717 W. 110th St., Suite 750
Overland Park,  KS  66210
Correspondent Contact ORLANDO CORDOVA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received01/30/1992
Decision Date 01/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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