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FDA 510(k) Application Details - K100905
Device Classification Name
Vessel Guard Or Cover
More FDA Info for this Device
510(K) Number
K100905
Device Name
Vessel Guard Or Cover
Applicant
MIMEDX GROUP, INC
811 LIVINGSTON COURT SE
SUITE B
MARIETTA, GA 30067 US
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Contact
LOUISE FOCHT
Other 510(k) Applications for this Contact
Regulation Number
870.3470
More FDA Info for this Regulation Number
Classification Product Code
OMR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2010
Decision Date
06/02/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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