FDA 510(k) Application Details - K042426

Device Classification Name Syringe, Antistick

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510(K) Number K042426
Device Name Syringe, Antistick
Applicant TAIJECT MEDICAL DEVICE CO., LTD.
P.O. BOX 8853
NEWPORT BEACH, CA 92658 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 09/08/2004
Decision Date 09/22/2004
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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