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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 K922461
Device Name COMFEEL WOUND DRESSING ORD
Applicant
Coloplast A/S
Water Gardens Pl. Suite 320
100 E. 15th St.
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Coloplast A/S
Water Gardens Pl. Suite 320
100 E. 15th St.
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/26/1992
Decision Date 08/17/1992
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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