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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 K923516
Device Name COMPOUND BENZOIN TINCTURE USP SEPP
Applicant
MEDI-FLEX HOSPITAL PRODUCTS, INC.
8717 W. 110TH ST., SUITE 750
OVERLAND PARK,  KS  66210 -2103
Applicant Contact ORLANDO CORDOVA
Correspondent
MEDI-FLEX HOSPITAL PRODUCTS, INC.
8717 W. 110TH ST., SUITE 750
OVERLAND PARK,  KS  66210 -2103
Correspondent Contact ORLANDO CORDOVA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/18/1992
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
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