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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Contact R. THOMAS GROTZ
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Regulation Number 890.3490

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Classification Product Code MRI
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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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