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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K180343
Device Name LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Applicant
Bonraybio Co., Ltd.
4F., No.118, Gongye 9th Rd. Dali Dist.
Taichung,  TW 41280
Applicant Contact Clare Huang
Correspondent
Dynamic Biotech Inc. dba IVDD Regulatory Consultant
29222 Rancho Viejo Road, Suite 218
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number864.5220
Classification Product Code
POV  
Subsequent Product Code
GKZ  
Date Received02/07/2018
Decision Date 11/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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