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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 K130040
Device Name MEPITEL AG
Applicant
Molnlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact ANGELA L BUNN
Correspondent
Molnlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact ANGELA L BUNN
Classification Product Code
FRO  
Date Received01/07/2013
Decision Date 02/12/2014
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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