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FDA 510(k) Application Details - K231117
Device Classification Name
Instrument, Ultrasonic Surgical
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510(K) Number
K231117
Device Name
Instrument, Ultrasonic Surgical
Applicant
Misonix, LLC, a Bioventus Company
1938 New Highway
Farmingdale, NY 11735 US
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Contact
John Salerno
Other 510(k) Applications for this Contact
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
04/20/2023
Decision Date
06/23/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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