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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, #100, Sec. 2
Heping E. Rd., Da'Am Dist.
Taipei,  TW 10663
Applicant Contact Hsin Hung Lai
Correspondent
Lin & Associates, LLC
5614 Johnson Ave.
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
Predetermined Change
Control Plan Authorized		 No
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