FDA 510(k) Application Details - K060002

Device Classification Name Syringe, Antistick

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510(K) Number K060002
Device Name Syringe, Antistick
Applicant RITRACT LTD.
201 MILLER STREET
LEVEL 17
NORTH SYDNEY, NEW SOUTH WALES 2060 AU
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Contact RUPERT NORTHCOTT
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 01/03/2006
Decision Date 06/02/2006
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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