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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K220611
Device Name SUREcore Plus Biopsy Instrument
Applicant
Uro-1, Inc.
3701-A Alliance Drive
Greensboro,  NC  27407
Applicant Contact Thomas Lawson
Correspondent
Uro-1, Inc.
3701-A Alliance Drive
Greensboro,  NC  27407
Correspondent Contact Thomas Lawson
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/03/2022
Decision Date 12/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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