510(k) K850754

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

K850754 is an FDA 510(k) premarket notification submitted by Mada Medical Products, Inc. for the device "MEDAJET XL - JET INJECTOR". The FDA issued a decision of Substantially Equivalent on December 10, 1985. The device falls under product code KZE (Injector, Fluid, Non-Electrically Powered), a Class II device regulated under 21 CFR 880.5430. Mada Medical Products, Inc. has at least 7 other 510(k) clearances on record.

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 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)

510(k) K850754

Clearance Details

Device Classification

Other clearances by Mada Medical Products, Inc.

Other clearances for product code KZE

FDA data resources