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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vessel Guard Or Cover
510(k) Number K100905
Device Name HYDROFIX SURGICAL SHEET
Applicant
MIMEDX GROUP, INC
811 LIVINGSTON COURT SE
SUITE B
MARIETTA,  GA  30067
Applicant Contact LOUISE FOCHT
Correspondent
MIMEDX GROUP, INC
811 LIVINGSTON COURT SE
SUITE B
MARIETTA,  GA  30067
Correspondent Contact LOUISE FOCHT
Regulation Number870.3470
Classification Product Code
OMR  
Date Received04/01/2010
Decision Date 06/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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