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510(k) K962017

HYPODERMIC JET INJECTION APPARATUS by American Jet Injector Corp. — Product Code EGM

K962017 is an FDA 510(k) premarket notification submitted by American Jet Injector Corp. for the device "HYPODERMIC JET INJECTION APPARATUS". The FDA issued a decision of Substantially Equivalent on July 26, 1996. 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
July 26, 1996
Date Received
May 23, 1996
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

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  • 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)
  • K790193 — MIZZY SYRIJET MARK IV (April 23, 1979)

FDA data resources