UNIVERSAL VIAL ACCESS SPIKE


Device Classification Name

syringe, piston

510(k) Number K080989
Device Name UNIVERSAL VIAL ACCESS SPIKE
Applicant
ICU MEDICAL, INC
4455 atherton dr.
salt lake city, 
UT 
84123

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

Correspodent Contact tracy best
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 04/07/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No