FDA 510(k) Application Details - K034031

Device Classification Name Syringe, Antistick

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510(K) Number K034031
Device Name Syringe, Antistick
Applicant M.K. MEDITECH CO. LTD.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact ROSINA ROBINSON
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 12/29/2003
Decision Date 01/21/2004
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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