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510(k) K011786

VACUETTE SAFETY BLOOD COLLECTION SET by Greiner Vacuette North America, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2001
Date Received
June 8, 2001
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 Vacuette North America, Inc.

  • K014104 — VACUETTE EDTA K2 TUBES (February 1, 2002)
  • K012043 — VACUETTE EDTA K2 GEL TUBES (September 24, 2001)
  • K003812 — VACUETTE SPEEDY QUICK-RELEASE HOLDER (April 30, 2001)
  • K002777 — VACUETTE WITH PPACK (October 5, 2000)

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