CLAVE STOPCOCK


Device Classification Name

stopcock, i.v. set

510(k) Number K080077
Device Name CLAVE STOPCOCK
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 880.5440
Classification Product Code
FMG  
Subsequent Product Code
LHI  
Date Received 01/11/2008
Decision Date 02/13/2008
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