FDA 510(k) Application Details - K083161

Device Classification Name Arthroscope

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510(K) Number K083161
Device Name Arthroscope
Applicant CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO, FL 33773-4908 US
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Contact SUE DAUTERMAN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 10/27/2008
Decision Date 03/27/2009
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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