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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 K970566
Device Name ARGLAES FILM DRESSING
Applicant
Maersk Medical, Ltd.
Thornhill Rd.,
North Moons Moat
Redditch, Worcestershire,  GB B98 9NL
Applicant Contact DAVID MITCHELL
Correspondent
Maersk Medical, Ltd.
Thornhill Rd.,
North Moons Moat
Redditch, Worcestershire,  GB B98 9NL
Correspondent Contact DAVID MITCHELL
Classification Product Code
FRO  
Date Received02/13/1997
Decision Date 07/29/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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