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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 Doppler, Ultrasonic
510(k) Number K170085
Device Name SONON Ultrasound Imaging System, Model: 300L
Applicant
Healcerion Co., Ltd.
804ho, 38-21, Digital-Ro 31-Gil,
Guro-Go
Seoul,  KR 08376
Applicant Contact JAEYEOB JUNG
Correspondent
The Allis Law Firm, Pllc
2437 Bay Area Blvd. #30
Houston,  TX  77058
Correspondent Contact CARMELINA G. ALLIS
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/10/2017
Decision Date 10/12/2017
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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