510(k) K090089

BELMONT HYPERTHERMIA PUMP by Belmont Instrument Corp. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2009
Date Received
January 14, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type