FDA 510(k) Application Details - K031909

Device Classification Name Syringe, Antistick

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510(K) Number K031909
Device Name Syringe, Antistick
Applicant BETEC MEDICAL SCIENCE 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 06/20/2003
Decision Date 10/07/2003
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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