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FDA 510(k) Application Details - K123588
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K123588
Device Name
Syringe, Piston
Applicant
WEST PHARMACEUTICAL SERVICES, INC.
101 GORDON DR.
LIONVILLE, PA 19341 US
Other 510(k) Applications for this Company
Contact
DEBBIE M THOMAS
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/21/2012
Decision Date
02/19/2013
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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