CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX


Device Classification Name

set, administration, intravascular

510(k) Number K081361
Device Name CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
Applicant
ICU MEDICAL INC
4455 atherton drive
salt lake city, 
UT 
84123

Applicant Contact tracy best
Correspondent
ICU MEDICAL INC
4455 atherton drive
salt lake city, 
UT 
84123

Correspodent Contact tracy best
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
LHI  
Date Received 05/15/2008
Decision Date 08/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No