FDA 510(k) Application Details - K093510

Device Classification Name	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position   More FDA Info for this Device
510(K) Number	K093510
Device Name	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
Applicant	SONOSITE,INC. 1835 MARKET ST., 29TH FL. PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE HOGAN Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	OMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2009
Decision Date	08/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review