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510(k) K960373

BIOJECTOR 2000 MODEL 1B02000 by Bioject, Inc. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1997
Date Received
January 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

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  • K003908 — SEROJET (March 8, 2001)
  • K994384 — CLICKER (June 22, 2000)
  • 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)

Other clearances for product code KZE

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  • K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (March 2, 2011)
  • K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (December 24, 2009)
  • K090003 — ZETAJET (April 2, 2009)
  • K081532 — PHARMAJET NEEDLE-FREE INJECTION SYSTEM (February 26, 2009)
  • K082138 — AIRGENT, MODEL AG7000010 (January 23, 2009)
  • K060819 — COOL.CLICK 2 (June 16, 2006)
  • K051985 — BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (August 17, 2005)
  • K050734 — COOL.CLICK (June 3, 2005)