FDA 510(k) Application Details - K082293

Device Classification Name Arthroscope

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510(K) Number K082293
Device Name Arthroscope
Applicant BIOVISION TECHNOLOGIES, LLC
221 CORPORATE CIRCLE
SUITE H
GOLDEN, CO 80401 US
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 08/12/2008
Decision Date 09/09/2008
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 Y
Expedited Review



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