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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name driver, wire, and bone drill, manual
510(k) Number K120956
Device Name VSP SYSTEM
Original Applicant
555 thirteenth street, nw
washington,  DC  20004
Original Contact jonathan s kahan
Regulation Number872.4120
Classification Product Code
Subsequent Product Code
Date Received03/30/2012
Decision Date 12/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No