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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tape and bandage, adhesive
510(k) Number K894916
Device Name COMFEEL TRANSPARENT DRESSING
Applicant
COLOPLAST A/S
C/O RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162
Applicant Contact RICHARD HAMER
Correspondent
COLOPLAST A/S
C/O RICHARD HAMER ASSOC., INC.
P.O. BOX 16598
FT. WORTH,  TX  76162
Correspondent Contact RICHARD HAMER
Regulation Number880.5240
Classification Product Code
KGX  
Date Received08/02/1989
Decision Date 09/26/1989
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
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