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FDA 510(k) Application Details - K202089
Device Classification Name
More FDA Info for this 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 41280 TW
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Contact
Brown Hsu
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Regulation Number
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Classification Product Code
POV
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More FDA Info for this Product Code
Date Received
07/28/2020
Decision Date
10/28/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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