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FDA 510(k) Application Details - K223265
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K223265
Device Name
Media, Reproductive
Applicant
Zhejiang Horizon Medical Technology Co., Ltd
Rom 219, 2nd floor, Building 9, 1303 Asia-Pacific Road,
Daqiao Town, Nanhu District
Jiaxing 314006 CN
Other 510(k) Applications for this Company
Contact
Wu Tang
Other 510(k) Applications for this Contact
Regulation Number
884.6180
More FDA Info for this Regulation Number
Classification Product Code
MQL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2022
Decision Date
05/11/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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