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FDA 510(k) Application Details - K191749
Device Classification Name
More FDA Info for this Device
510(K) Number
K191749
Device Name
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
Applicant
Novus Scientific AB
Virdings Alle 2
Uppsala se-754 50 SE
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Contact
Thomas Engstrom
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OWT
Other 510(k) Applications for this Device
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Date Received
07/01/2019
Decision Date
03/26/2020
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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