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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K090959
Device Name LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
Applicant
D'Antonio Consultants International, Inc. (Dci)
6308 Fly Rd.
East Syracuse,  NY  13057
Applicant Contact JOSEPH P D'ANTONIO
Correspondent
D'Antonio Consultants International, Inc. (Dci)
6308 Fly Rd.
East Syracuse,  NY  13057
Correspondent Contact JOSEPH P D'ANTONIO
Regulation Number880.5430
Classification Product Code
KZE  
Date Received04/06/2009
Decision Date 12/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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