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FDA 510(k) Application Details - K153633
Device Classification Name
Mesh, Surgical
More FDA Info for this Device
510(K) Number
K153633
Device Name
Mesh, Surgical
Applicant
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
2 Kingsford Smith Place, Airport Oaks
Auckland 2022 NZ
Other 510(k) Applications for this Company
Contact
Yasmin Rai
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2015
Decision Date
03/15/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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