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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 K851029
Device Name NEW VITAJET
Applicant
ANDREW V. STADLER
204 CLIFF DRIVE #3
LAGUNA BEACH,  CA  92651
Applicant Contact ANDREW V STADLER
Correspondent
ANDREW V. STADLER
204 CLIFF DRIVE #3
LAGUNA BEACH,  CA  92651
Correspondent Contact ANDREW V STADLER
Regulation Number880.5430
Classification Product Code
KZE  
Date Received03/12/1985
Decision Date 05/23/1985
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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