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FDA 510(k) Application Details - K141464
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K141464
Device Name
Syringe, Antistick
Applicant
WEST PHARMACEUTICAL SERVICES
530 HERMAN O. WEST DRIVE
EXTON, PA 19341-1147 US
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Contact
KEVIN LENTZ
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
MEG
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More FDA Info for this Product Code
Date Received
06/03/2014
Decision Date
09/10/2014
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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