TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K122249
Device Name TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
Applicant
TERUMO (PHILIPPINES) CORPORATION
950 elkton blvd
elkton, 
MD 
21921

Applicant Contact phillip lester
Correspondent
TERUMO (PHILIPPINES) CORPORATION
950 elkton blvd
elkton, 
MD 
21921

Correspodent Contact phillip lester
Regulation Number 880.5570
Classification Product Code
FMI  
Subsequent Product Code
MEG  
Date Received 07/27/2012
Decision Date 08/28/2012
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