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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 K954857
Device Name COMFEEL:ALGINATE FILLER
Applicant
COLOPLAST CORP.
100 E. 15TH ST.
SUITE 320
FORT WORTH,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
COLOPLAST CORP.
100 E. 15TH ST.
SUITE 320
FORT WORTH,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/23/1995
Decision Date 11/14/1995
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
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