FDA 510(k) Application Details - K012640

Device Classification Name Arthroscope

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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
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Regulation Number 888.1100

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Classification Product Code HRX
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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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