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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Jet, Mechanical-Powered
510(k) Number K964802
Device Name CYBERJET LOCAL ANESTHESIA SYSTEM
Applicant
Intra Vantage, Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Intra Vantage, Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number872.4475
Classification Product Code
EGM  
Date Received11/29/1996
Decision Date 05/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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