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FDA 510(k) Application Details - K012640
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K012640
Device Name
Arthroscope
Applicant
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
385 NORTH 3050 EAST
ST. GEORGE, UT 84790 US
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Contact
JACK SPEER
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2001
Decision Date
02/28/2002
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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