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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 K023458
Device Name TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
Applicant
TAIJECT MEDICAL DEVICE CO., LTD.
19502 SIERRA MIA RD.
IRVINE,  CA  92612
Applicant Contact JIM-SON CHOU
Correspondent
TAIJECT MEDICAL DEVICE CO., LTD.
19502 SIERRA MIA RD.
IRVINE,  CA  92612
Correspondent Contact JIM-SON CHOU
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMI  
Date Received10/15/2002
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
Predetermined Change
Control Plan Authorized		 No
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