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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
Predetermined Change
Control Plan Authorized		 No
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