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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K192033
Device Name Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
Applicant
Bennett Jacoby, DDS, MS, Inc.
77-6425 Kuakini Hwy, C2-84
Kailua Kona,  HI  96740
Applicant Contact Bennett Jacoby
Correspondent
Contract In-House Counsel & Consultants, LLC (d/b/a FDA Atty
53516 Bickett
Chapel Hill,  NC  27517
Correspondent Contact Marc C. Sanchez
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received07/30/2019
Decision Date 06/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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