FDA 510(k) Application Details - K040105

Device Classification Name Syringe, Antistick

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510(K) Number K040105
Device Name Syringe, Antistick
Applicant YUE PFONG INTERNATIONAL INDUSTRIAL CO., LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF, AZ 86001 US
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Contact JENNIFER REICH
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 01/20/2004
Decision Date 04/07/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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