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FDA 510(k) Application Details - K212060
Device Classification Name
Instrument, Ultrasonic Surgical
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510(K) Number
K212060
Device Name
Instrument, Ultrasonic Surgical
Applicant
Misonix Inc.
1938 New Highway
Farmingdale, NY 11735 US
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Contact
John Salerno
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Regulation Number
000.0000
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Classification Product Code
LFL
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More FDA Info for this Product Code
Date Received
07/01/2021
Decision Date
12/13/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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