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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 K202089
Device Name LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
Applicant
Bonraybio Co., Ltd.
4F., No.118, Gongye 9th Rd. Dali Dist.
Taichung,  TW 41280
Applicant Contact Brown Hsu
Correspondent
Dynamic Biotech, Inc dba. IVDD Regulatory Consultant
29122 Rancho Viejo Rd., Suite 212
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number864.5220
Classification Product Code
POV  
Date Received07/28/2020
Decision Date 10/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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