FDA 510(k) Application Details - K223406

Device Classification Name Arthroscope

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510(K) Number K223406
Device Name Arthroscope
Applicant MicroAire Surgical Instruments
3590 Grand Forks Blvd
Charlottesville, VA 22911 US
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Contact Glenn Gerstenfeld
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 11/09/2022
Decision Date 02/02/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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