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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact