FDA 510(k) Application Details - K993021

Device Classification Name Arthroscope

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510(K) Number K993021
Device Name Arthroscope
Applicant SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD, CO 80020 US
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Contact ROGER N WHITE
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/08/1999
Decision Date 11/10/1999
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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