SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)


Device Classification Name

set, administration, intravascular

510(k) Number K072894
Device Name SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
Applicant
TERUMO EUROPE N.V.
researchpark zone 2
interleuvenlaan 40
leuven, 

BE

3001

Applicant Contact m.j. aerts
Correspondent
TERUMO EUROPE N.V.
researchpark zone 2
interleuvenlaan 40
leuven, 

BE

3001

Correspodent Contact m.j. aerts
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 10/11/2007
Decision Date 11/06/2007
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