K-PACK II NEEDLE- 27G & 30G THIN WALL


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K110850
Device Name K-PACK II NEEDLE- 27G & 30G THIN WALL
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 03/28/2011
Decision Date 06/09/2011
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