FDA 510(k) Application Details - K023458

Device Classification Name Syringe, Antistick

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510(K) Number K023458
Device Name Syringe, Antistick
Applicant TAIJECT MEDICAL DEVICE CO., LTD.
19502 SIERRA MIA RD.
IRVINE, CA 92612 US
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Contact JIM-SON CHOU
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 10/15/2002
Decision Date 11/07/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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