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FDA 510(k) Application Details - K192636
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K192636
Device Name
Mesh, Surgical, Polymeric
Applicant
Medtronic, Inc.
8200 Coral Sea St NE
Mounds View, MN 55112 US
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Contact
Nancy Cameron
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
09/23/2019
Decision Date
04/08/2020
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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