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FDA 510(k) Applications Submitted by Brenna Loufek
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180873
04/03/2018
Medtronic Model 53401 External Pulse Generator (EPG)
Medtronic, Inc.
K211597
05/24/2021
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Medical Systems
K181973
07/24/2018
Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc.
K212704
08/26/2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
Philips Medical Systems
K162550
09/13/2016
Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc.
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