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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 K941263
Device Name COMFEEL PLUS WOUND DRESSING
Applicant
Richard Hamer Assoc., Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Applicant Contact MAX FURIMSKY
Correspondent
Richard Hamer Assoc., Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Correspondent Contact MAX FURIMSKY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/16/1994
Decision Date 05/10/1994
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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