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FDA 510(k) Application Details - K093863
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K093863
Device Name
Syringe, Piston
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET TA1 2LB GB
Other 510(k) Applications for this Company
Contact
MARGARET BLACKMORE
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
12/17/2009
Decision Date
05/10/2010
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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