FDA 510(k) Application Details - K020457

Device Classification Name Arthroscope

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510(K) Number K020457
Device Name Arthroscope
Applicant AXIAMED, INC.
5200 WILSON RD.
SUITE 150
EDINA, MN 55424 US
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Contact W ALLEN PUTNAM
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 02/11/2002
Decision Date 09/26/2002
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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