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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K100313
Device Name HYDROFIX SURGICAL SHEET
Applicant
Mimedx Group, Inc.
811 Livingston Court SE
Suite B
Marietta,  GA  30067
Applicant Contact SALLY THORSEN
Correspondent
Mimedx Group, Inc.
811 Livingston Court SE
Suite B
Marietta,  GA  30067
Correspondent Contact SALLY THORSEN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/04/2010
Decision Date 06/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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