SMARTSITE STOPCOCK

Device Classification Name

stopcock, i.v. set

510(k) Number K071400
Device Name SMARTSITE STOPCOCK
Applicant
CARDINAL HEALTH, ALARIS PRODUCTS
10221 wateridge circle
san diego, 
CA 
92121 -2772

Applicant Contact stacy l lewis
Correspondent
CARDINAL HEALTH, ALARIS PRODUCTS
10221 wateridge circle
san diego, 
CA 
92121 -2772

Correspodent Contact stacy l lewis
Regulation Number 880.5440
Classification Product Code
FMG  
Date Received 05/21/2007
Decision Date 12/14/2007
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