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FDA 510(k) Application Details - K032891
Device Classification Name
Arthroscope
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.1100
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Classification Product Code
HRX
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More FDA Info for this Product Code
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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