FDA.reportPublic FDA data

510(k) K220785

Device
Clean Connecting Tube
Applicant
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
510(k) number
K220785
Product code
OCX
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-27
Date received
2022-03-17
Regulation
876.1500
Classification name
Endoscopic Irrigation/Suction System
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tina Han
Address
Beizhou Rd., Lidian Town, Guangling District Yangzhou CN 225106 225106

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCX#

510(k), Device, Applicant table
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