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510(k) K850754

MEDAJET XL - JET INJECTOR by Mada Medical Products, Inc. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1985
Date Received
February 25, 1985
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 Mada Medical Products, Inc.

  • K003862 — MADA WHEELCHAIRS (January 12, 2001)
  • K002943 — WHEELCHAIR, MECHANICAL SERIES MODEL 3100 (October 23, 2000)
  • K950777 — OXYGEN REGULATOR (April 14, 1995)
  • K930947 — PROMENADE (June 1, 1993)
  • K930949 — VOYAGE (June 1, 1993)
  • K921611 — MADAVAC 190 (September 9, 1992)
  • K802426 — RESPO2 OXYGEN CONCENTRATOR (October 23, 1980)

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)
  • K050734 — COOL.CLICK (June 3, 2005)