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FDA 510(k) Application Details - K963091
Device Classification Name
Orthosis, Thoracic
More FDA Info for this Device
510(K) Number
K963091
Device Name
Orthosis, Thoracic
Applicant
HILL-ROM, INC.
4349 CORPORATE RD.
CHARLESTON, SC 29405 US
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EDWIN L BILLS
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Regulation Number
890.3490
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Classification Product Code
IPT
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More FDA Info for this Product Code
Date Received
08/08/1996
Decision Date
01/09/1997
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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