510(k) K090959

LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA by D'Antonio Consultants International, Inc. (Dci) — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2009
Date Received
April 6, 2009
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