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FDA 510(k) Application Details - K181819
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K181819
Device Name
Arthroscope
Applicant
MicroAire Surgical Instruments LLC
3590 Grand Forks Blvd
Charlottesville, VA 22911 US
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Contact
Glenn Gerstenfeld
Other 510(k) Applications for this Contact
Regulation Number
888.1100
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Classification Product Code
HRX
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More FDA Info for this Product Code
Date Received
07/09/2018
Decision Date
11/06/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
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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