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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K211098
Device Name Breast Volume Navigator (BVN) Model G-2000
Applicant
Metritrack, Inc.
4415 W. Harrison St.
Suite 243
Hillside,  IL  60162
Applicant Contact Mirela Wohlford
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
LLZ  
Date Received04/13/2021
Decision Date 05/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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