FDA 510(k) Application Details - K072566

Device Classification Name Orthosis, Cranial, Laser Scan

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510(K) Number K072566
Device Name Orthosis, Cranial, Laser Scan
Applicant HANGER PROSTHETICS & ORTHOTICS, INC.
700 12TH STREET, NW
WASHINGTON, DC 20005 US
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Contact IVAN J WASSERMAN
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Regulation Number 882.5970

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Classification Product Code OAN
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Date Received 09/12/2007
Decision Date 01/09/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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