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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 K942283
Device Name COMFEEL PLUS TRANSPARENT DRESSING
Applicant
Richard Hamer Assoc., Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Richard Hamer Assoc., Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/11/1994
Decision Date 07/29/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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