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FDA 510(k) Application Details - K161020
Device Classification Name
More FDA Info for this Device
510(K) Number
K161020
Device Name
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
Applicant
REVMEDX, INC.
25999 SW CANYON CREEK ROAD
SUITE C
WILSONVILLE, OR 97070 US
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Contact
AMY K. POINTER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/12/2016
Decision Date
07/28/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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