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510(k) K121908

SAFETY INFUSION SET by Greiner Bio-One North America, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
June 29, 2012
Clearance Type
Special
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

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  • K102774 — VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER (October 15, 2010)
  • K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR (December 16, 2008)
  • K072320 — GREINER VACUETTE QUICKSHIELD COMPLETE (September 14, 2007)
  • K063357 — MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES (July 10, 2007)
  • K061483 — VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES (August 14, 2006)

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