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FDA 510(k) Application Details - K180122
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K180122
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
01/16/2018
Decision Date
06/07/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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