FDA 510(k) Application Details - K060346

Device Classification Name	System, Ablation, Ultrasound And Accessories   More FDA Info for this Device
510(K) Number	K060346
Device Name	System, Ablation, Ultrasound And Accessories
Applicant	ULTRAZONIX DNT AB 7307 GLOUCHESTER DRIVE EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NTB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2006
Decision Date	12/22/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review