FDA.report

510(k) K182463

Device
Silicone Foley Catheter
Applicant
Biosensors International Pte Ltd
510(k) number
K182463
Product code
EZL  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-06
Date received
2018-09-10
Regulation
876.5130
Classification name
Catheter, Retention Type, Balloon
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Lor Yen Yin
Address
36 Jalan Tukang Singapore SG 619266 619266

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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