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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K022278
Device Name TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
Applicant
TAIJECT MEDICAL DEVICE CO., LTD.
P.O. BOX 8853
NEWPORT BEACH,  CA  92658
Applicant Contact JIM-SON CHOU
Correspondent
TAIJECT MEDICAL DEVICE CO., LTD.
P.O. BOX 8853
NEWPORT BEACH,  CA  92658
Correspondent Contact JIM-SON CHOU
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMI  
Date Received07/15/2002
Decision Date 09/12/2002
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
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