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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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More FDA Info for this Product Code
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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