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FDA 510(k) Application Details - K180109
Device Classification Name
Orthosis, Cranial, Laser Scan
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510(K) Number
K180109
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 C. Kerr
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
01/16/2018
Decision Date
03/01/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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