FDA 510(k) Application Details - K101734

Device Classification Name Arthroscope

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510(K) Number K101734
Device Name Arthroscope
Applicant VISIONSCOPE TECHNOLOGIES, LLC
2352 MAIN STREET
SUITE 303
CONCORD, MA 01742 US
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Contact LIM CHEUNG PH.D
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 06/21/2010
Decision Date 09/08/2010
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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