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FDA 510(k) Application Details - K090162
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K090162
Device Name
Syringe, Piston
Applicant
OMRIX BIOPHARMACEUTICALS LTD.
MDA BLOOD BANK
SHEBA HOSPITAL, TEL HASHOMER
RAMAT GAN 52621 IL
Other 510(k) Applications for this Company
Contact
SARA HORN
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
01/22/2009
Decision Date
02/20/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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