ARCTIC BLAST INTRAVENOUS FLUID CHILLER


Device Classification Name

system, hypothermia, intravenous, cooling

510(k) Number K080899
Device Name ARCTIC BLAST INTRAVENOUS FLUID CHILLER
Applicant
MEDIVANCE, INC.
1172 century dr., suite 240
louisville, 
CO 
80027

Applicant Contact lynne aronson
Correspondent
MEDIVANCE, INC.
1172 century dr., suite 240
louisville, 
CO 
80027

Correspodent Contact lynne aronson
Regulation Number 870.5900
Classification Product Code
NCX  
Date Received 03/31/2008
Decision Date 08/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No