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FDA 510(k) Application Details - K140353
Device Classification Name
Orthosis, Cranial
More FDA Info for this Device
510(K) Number
K140353
Device Name
Orthosis, Cranial
Applicant
ORTHOMERICA PRODUCTS, INC.
6333 N Orange Blossom Trl
ORLANDO, FL 32810 US
Other 510(k) Applications for this Company
Contact
DAVID L HOOPER
Other 510(k) Applications for this Contact
Regulation Number
882.5970
More FDA Info for this Regulation Number
Classification Product Code
MVA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2014
Decision Date
06/06/2014
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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