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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
Cahpel 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
Predetermined Change
Control Plan Authorized		 No
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