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FDA 510(k) Application Details - K182255
Device Classification Name
Mesh, Surgical
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510(K) Number
K182255
Device Name
Mesh, Surgical
Applicant
Aziyo Biologics, Inc.
1100 Old Ellis Road, Suite 1200
Roswell, GA 30076 US
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Contact
Wendy Perreault
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Regulation Number
878.3300
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Classification Product Code
FTM
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More FDA Info for this Product Code
Date Received
08/20/2018
Decision Date
11/15/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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