FDA 510(k) Application Details - K092366

Device Classification Name Warmer, Thermal, Infusion Fluid

  More FDA Info for this Device
510(K) Number K092366
Device Name Warmer, Thermal, Infusion Fluid
Applicant THERMAL THERAPEUTIC SYSTEMS, INC
PO BOX 961
MOON TOWNSHIP, PA 15108 US
Other 510(k) Applications for this Company
Contact JAMES J ROGERS
Other 510(k) Applications for this Contact
Regulation Number 000.0000

  More FDA Info for this Regulation Number
Classification Product Code LGZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/05/2009
Decision Date 03/04/2010
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact