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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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More FDA Info for this Product Code
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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