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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 K231677
Device Name EdgeFlow UH10
Applicant
Edgecare Inc.
403, Teihard Hall, 35, Baekbeom-ro, Mapo-gu
Seoul,  KR 04107
Applicant Contact Park Sangeun
Correspondent
KMC, Inc.
Room no. 1709, 123, Digital-ro 26-gil, Guro-gu
Seoul,  KR 08390
Correspondent Contact Milly .
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   QIH  
Date Received06/09/2023
Decision Date 03/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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