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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 K962625
Device Name VITAJET
Applicant
Vitajet Corp.
27075 Cabot Rd.
Suite 102
Laguna Hills,  CA  92653
Applicant Contact SERGIO LANDAU
Correspondent
Vitajet Corp.
27075 Cabot Rd.
Suite 102
Laguna Hills,  CA  92653
Correspondent Contact SERGIO LANDAU
Regulation Number880.5430
Classification Product Code
KZE  
Date Received07/05/1996
Decision Date 12/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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