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FDA 510(k) Application Details - K142141
Device Classification Name
Orthosis, Cranial, Laser Scan
More FDA Info for this Device
510(K) Number
K142141
Device Name
Orthosis, Cranial, Laser Scan
Applicant
ORTHOMERICA PRODUCTS, INC.
6333 North Orange Blossom Trail
Orlando, FL 32810 US
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Contact
DAVID L.HOOPER
Other 510(k) Applications for this Contact
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
08/05/2014
Decision Date
04/23/2015
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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