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FDA 510(k) Application Details - K923880
Device Classification Name
Orthosis, Truncal/Orthosis, Limb
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510(K) Number
K923880
Device Name
Orthosis, Truncal/Orthosis, Limb
Applicant
MOPAC, LTD.
P.O. BOX 3094
EAU CLAIRE, WI 54702 US
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Contact
JOHN STAHL
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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
07/31/1992
Decision Date
09/30/1996
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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