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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 K171309
Device Name BR-FHUS Navigation 1.0
Applicant
TaiHao Medical Inc.
3F.-8, No.100, Sec. 2
Heping E. Rd., Da'am Dist.
taipei,  TW 10663
Applicant Contact hsin hung lai
Correspondent
Lin & Associates, LLC
5614 Johnson Avenue
bethesda,  MD  20817
Correspondent Contact chiu s. lin
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/03/2017
Decision Date 09/29/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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