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FDA 510(k) Application Details - K171286
Device Classification Name
More FDA Info for this Device
510(K) Number
K171286
Device Name
PAL Multi-Use Cannulas and PAL Manual Wand
Applicant
MicroAire Surgical Instruments, LLC
3590 Grans Forks Blvd
Charlottesville, VA 22911 US
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Contact
Glenn Gerstenfeld
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QPB
Other 510(k) Applications for this Device
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Date Received
05/01/2017
Decision Date
10/13/2017
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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