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510(k) K061483

VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES by Greiner Bio-One North America, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2006
Date Received
May 30, 2006
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 Greiner Bio-One North America, Inc.

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  • K122687 — BLOOD CULTURE HOLDER (January 10, 2013)
  • K121908 — SAFETY INFUSION SET (July 25, 2012)
  • K113505 — VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER (February 17, 2012)
  • K103041 — VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR (November 9, 2010)
  • 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)

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