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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 K883588
Device Name COMPEED ATHLETIC DRESSING
Applicant
Coloplast A/S
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
Coloplast A/S
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Correspondent Contact RICHARD A HAMER
Classification Product Code
FRO  
Date Received08/22/1988
Decision Date 09/22/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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