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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 K151339
Device Name SONON Ultrasound Imaging System (Model: SONON 300C)
Applicant
Healcerion Co., Ltd.
(Guro-Dong, Changup Jiwon Center), 72, Digital-R0 26-Gil,
Guro-Gu
Seoul,  KR 151-848
Applicant Contact JAEYEOB JUNG
Correspondent
The Allis Law Firm, Pllc
2437 Bay Area Blvd. #30
Houston,  TX  77058
Correspondent Contact CARMELINA G ALLIS
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received05/19/2015
Decision Date 09/10/2015
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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