TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)


Device Classification Name

syringe, antistick

510(k) Number K023458
Device Name TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
Original Applicant
TAIJECT MEDICAL DEVICE CO., LTD.
19502 sierra mia rd.
irvine, 
CA 
92612

Original Contact jim-son chou
Regulation Number 880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMI  
Date Received 10/15/2002
Decision Date 11/07/2002
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