FDA 510(k) Application Details - K081787

Device Classification Name	Orthosis, Cranial, Laser Scan   More FDA Info for this Device
510(K) Number	K081787
Device Name	Orthosis, Cranial, Laser Scan
Applicant	BIOSCULPTOR CORPORATION 2480 WEST 82ND STREET #8 HIALEAH, FL 33016 US Other 510(k) Applications for this Company
Contact	MARK MAZLOFF 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	06/24/2008
Decision Date	01/27/2009
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