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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K924447
Device Name VITAPEN
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 Number880.6320
Classification Product Code
KZF  
Date Received09/01/1992
Decision Date 09/27/1993
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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