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510(k) K010623

RECONSTITUTION KIT & VIAL CONNECTOR by Bioject, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2001
Date Received
March 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Bioject, Inc.

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  • K994384 — CLICKER (June 22, 2000)
  • K960373 — BIOJECTOR 2000 MODEL 1B02000 (March 5, 1997)
  • K963012 — BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) (October 15, 1996)
  • K920631 — BIOJECT JET INJECTION SYSTEM (June 28, 1994)
  • K861687 — BIOJECTOR SYRINGE SYSTEM (April 23, 1987)

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