Home / 510(k) Clearances / K790193

510(k) K790193

MIZZY SYRIJET MARK IV by Mizzy, Inc. — Product Code EGM

K790193 is an FDA 510(k) premarket notification submitted by Mizzy, Inc. for the device "MIZZY SYRIJET MARK IV". The FDA issued a decision of Substantially Equivalent on April 23, 1979. The device falls under product code EGM (Injector, Jet, Mechanical-Powered), a Class II device regulated under 21 CFR 872.4475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1979
Date Received
January 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Jet, Mechanical-Powered
Device Class
Class II
Regulation Number
872.4475
Review Panel
DE
Submission Type

Other clearances for product code EGM

  • K243427 — QuickSleeper 5 (August 1, 2025)
  • K083811 — W&H HANDPIECE ANESTO, MODEL: RA-5 (January 14, 2010)
  • K964802 — CYBERJET LOCAL ANESTHESIA SYSTEM (May 27, 1997)
  • K962017 — HYPODERMIC JET INJECTION APPARATUS (July 26, 1996)
  • K904279 — PAROJECT ANESTHETIC SYRINGE (December 7, 1990)
  • K864294 — HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (November 4, 1987)
  • K864732 — GRADTECH SYRINGE SYSTEM (April 15, 1987)
  • K864861 — INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM (February 13, 1987)
  • K834361 — JSB JET SYRINGE (March 5, 1984)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)

FDA data resources