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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cord, retraction
510(k) Number K200764
Device Name STATSTIX
Centrix Incorporated
770 River Road
Shelton,  CT  06484
Applicant Contact Greg Moreau
MedTek LLC
2516 Kettle Creek Court
Lincolnton,  NC  28092
Correspondent Contact Roger S Mastrony
Classification Product Code
Subsequent Product Code
Date Received03/24/2020
Decision Date 10/15/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No