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FDA 510(k) Application Details - K973031
Device Classification Name
Orthosis, Truncal/Orthosis, Limb
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510(K) Number
K973031
Device Name
Orthosis, Truncal/Orthosis, Limb
Applicant
R. THOMAS GROTZ, M.D., INC.
530 BUSH STREET, 10TH FLOOR
SAN FRANCISCO, CA 94108 US
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R. THOMAS GROTZ
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Regulation Number
890.3490
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Classification Product Code
MRI
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More FDA Info for this Product Code
Date Received
08/14/1997
Decision Date
11/03/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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