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FDA 510(k) Application Details - K130900
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K130900
Device Name
Syringe, Piston
Applicant
ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS
ROUTE 22 WEST
SOMERVILLE, NJ 08876 US
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Contact
SHIKHA GOLA
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
04/01/2013
Decision Date
08/13/2013
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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