FDA 510(k) Application Details - K100447

Device Classification Name	Device, Surgical, Cryogenic   More FDA Info for this Device
510(K) Number	K100447
Device Name	Device, Surgical, Cryogenic
Applicant	MYOSCIENCE INC 525 CHESAPEAKE DRIVE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	TRACEY HENRY Other 510(k) Applications for this Contact
Regulation Number	882.4250   More FDA Info for this Regulation Number
Classification Product Code	GXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2010
Decision Date	06/25/2010
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