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510(k) K050734

COOL.CLICK by Bioject, Inc. — Product Code KZE

K050734 is an FDA 510(k) premarket notification submitted by Bioject, Inc. for the device "COOL.CLICK". The FDA issued a decision of Substantially Equivalent on June 3, 2005. The device falls under product code KZE (Injector, Fluid, Non-Electrically Powered), a Class II device regulated under 21 CFR 880.5430. Bioject, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2005
Date Received
March 21, 2005
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

Other clearances by Bioject, Inc.

  • K090003 — ZETAJET (April 2, 2009)
  • K010623 — RECONSTITUTION KIT & VIAL CONNECTOR (April 5, 2001)
  • K003908 — SEROJET (March 8, 2001)
  • 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)

Other clearances for product code KZE

  • K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (July 19, 2012)
  • K111517 — PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJE (July 27, 2011)
  • 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)
  • K041239 — GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 (November 8, 2004)

FDA data resources