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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K840438
Device Name COMFEEL ULCUS SHEET
Applicant
Coloplast A/S
200 W. 7th. St.
Suite 1512
Fort Worth ,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Coloplast A/S
200 W. 7th. St.
Suite 1512
Fort Worth ,  TX  76102
Correspondent Contact RICHARD A HAMER
Classification Product Code
FRO  
Date Received02/01/1984
Decision Date 11/07/1984
Decision Substantially Equivalent (SESE)
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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