FDA 510(k) Application Details - K032891

Device Classification Name Arthroscope

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510(K) Number K032891
Device Name Arthroscope
Applicant TRANS1, INC.
6285 CHASKA ROAD
EXCELSIOR, MN 55331 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 09/17/2003
Decision Date 01/15/2004
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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