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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 K031062
Device Name TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
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  
Date Received04/03/2003
Decision Date 05/02/2003
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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