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510(k) K120661

THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE by Vidacare Corporation — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2012
Date Received
March 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Vidacare Corporation

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  • K101026 — POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO (July 27, 2010)
  • K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, (October 14, 2009)
  • K081713 — VERTEBRAL ACCESS SYSTEM BY VIDACARE (November 21, 2008)
  • K072045 — ONCONTROL BONE MARROW BIOPSY SYSTEM (October 22, 2007)
  • K070759 — POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM (May 21, 2007)
  • K063567 — EZ-MIO STERNAL (January 26, 2007)
  • K063142 — MANUAL PD-IO; POWERED PD-IO (December 8, 2006)
  • K062956 — EZ-MIO, EZ-IO DISTAL TIBIA (December 5, 2006)

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