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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 K201353
Device Name CenterMed Patient Matched Assisted Surgical Planning (ASP) System
Applicant
Centermed, Inc.
226 N Wiget Ln
Walnut Creek,  CA  94598
Applicant Contact Christine Yu
Correspondent
Scientific Solutions R US
226 N Wiget Ln
Walnut Creek,  CA  94598
Correspondent Contact Jash Bhayani
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received05/21/2020
Decision Date 06/28/2021
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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