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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
TaiHao Medical Inc.
3F.-8, No.100, Sec. 2
Heping E. Rd., Da'am Dist.
Taipei,  TW 10663
Applicant Contact Hsin Hung Lai
Lin & Associates, LLC
5614 Johnson Avenue
Bethesda,  MD  20817
Correspondent Contact Chiu S. Lin
Regulation Number892.1560
Classification Product Code
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