K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K110527
Device Name K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
Applicant
TERUMO EUROPE N.V.
interleuvenlaan 40
leuven, 

BE

3001

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

BE

3001

Correspodent Contact m. j aerts
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 02/24/2011
Decision Date 06/06/2011
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