FDA 510(k) Application Details - K171286

Device Classification Name

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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
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Regulation Number

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Classification Product Code QPB
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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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