FDA 510(k) Application Details - K030604

Device Classification Name Syringe, Antistick

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510(K) Number K030604
Device Name Syringe, Antistick
Applicant PERFECT MEDICAL INDUSTRY CO., LTD.
6833 SAINT LAWRENCE ST.
PLANO, TX 75024 US
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Contact ERIC LUO
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 02/25/2003
Decision Date 04/30/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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