FDA 510(k) Application Details - K090303

Device Classification Name Arthroscope

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510(K) Number K090303
Device Name Arthroscope
Applicant CORESPINE TECHNOLOGIES, LLC
5909 BAKER ROAD
SUITE 550
MINNEAPOLIS, MN 55345 US
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Contact BRITT K NORTON
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 02/06/2009
Decision Date 04/30/2009
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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