FDA 510(k) Application Details - K141664

Device Classification Name Syringe, Antistick

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510(K) Number K141664
Device Name Syringe, Antistick
Applicant REXAM HEALTHCARE
20 AVENUE DE LA GARE
LA VERPILLIERE 38292 FR
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Contact BEATRICE GRAND DEMARS
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 06/23/2014
Decision Date 10/02/2014
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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