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510(k) K080235

SAFETY INFUSION SET by Greiner Bio-One Vacuette North America — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2008
Date Received
January 30, 2008
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 Vacuette North America

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  • K033478 — VACUETTE QUICKSHIELD SAFETY TUBE HOLDER (December 29, 2003)
  • K023971 — VACUETTE TRACE ELEMENTS TUBES (January 27, 2003)
  • K011699 — VACUETTE EVACUATED BLOOD COLLECTION TUBES (June 28, 2001)

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