FDA 510(k) Application Details - K083335

Device Classification Name	More FDA Info for this Device
510(K) Number	K083335
Device Name	MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
Applicant	OMNISONICS MEDICAL TECHNOLOGIES 66 CONCORD STREET, SUITE A WILMINGTON, MA 01887 US Other 510(k) Applications for this Company
Contact	ANNE M KULIS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2008
Decision Date	12/15/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review