Last synced on 25 November 2022 at 11:04 pm

Silicone Foley Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182463
510(k) Type
Traditional
Applicant
Biosensors International Pte Ltd
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
11/6/2019
Days to Decision
422 days
Submission Type
Summary

Silicone Foley Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182463
510(k) Type
Traditional
Applicant
Biosensors International Pte Ltd
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
11/6/2019
Days to Decision
422 days
Submission Type
Summary