FDA 510(k) Application Details - K062780

Device Classification Name Syringe, Antistick

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510(K) Number K062780
Device Name Syringe, Antistick
Applicant MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
7/145 MOO 4
AMATA CITY INDUSTRIAL ESTATE
RAYONG 21140 TH
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Contact OYTIP KUNWUNLOP
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 09/18/2006
Decision Date 01/05/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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