FDA 510(k) Application Details - K963091

Device Classification Name Orthosis, Thoracic

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510(K) Number K963091
Device Name Orthosis, Thoracic
Applicant HILL-ROM, INC.
4349 CORPORATE RD.
CHARLESTON, SC 29405 US
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Contact EDWIN L BILLS
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Regulation Number 890.3490

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Classification Product Code IPT
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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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