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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 K071354
FOIA Releasable 510(k) K071354
Device Name MEPILEX AG DRESSING
Applicant
Monlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact STEVEN DOWDLEY
Correspondent
Monlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact STEVEN DOWDLEY
Classification Product Code
FRO  
Date Received05/15/2007
Decision Date 07/13/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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