FDA 510(k) Application Details - K151147

Device Classification Name Orthosis, Cranial, Laser Scan

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510(K) Number K151147
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
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Regulation Number 882.5970

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Classification Product Code OAN
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Date Received 04/30/2015
Decision Date 07/01/2015
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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