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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Skin Pressure
510(k) Number K951325
Device Name COMFEEL PLUS PRESSURE RELIEF DRESSING
Applicant
RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162 -0598
Applicant Contact RICHARD A HAMER
Correspondent
RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162 -0598
Correspondent Contact RICHARD A HAMER
Regulation Number880.6450
Classification Product Code
FMP  
Date Received03/23/1995
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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