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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 K202012
Device Name Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati,  OH  45241
Applicant Contact Gwendolyn P. Payne
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number876.1075
Classification Product Code
Date Received07/21/2020
Decision Date 08/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No