FDA 510(k) Application Details - K021918

Device Classification Name	Orthosis, Cranial, Laser Scan   More FDA Info for this Device
510(K) Number	K021918
Device Name	Orthosis, Cranial, Laser Scan
Applicant	ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL ORLANDO, FL 32810 US Other 510(k) Applications for this Company
Contact	DEANNA FISH Other 510(k) Applications for this Contact
Regulation Number	882.5970   More FDA Info for this Regulation Number
Classification Product Code	OAN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2002
Decision Date	07/25/2002
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