Last synced on 25 November 2022 at 11:04 pm

SpeediCath Standard

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180258
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2018
Days to Decision
268 days
Submission Type
Summary

SpeediCath Standard

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180258
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2018
Days to Decision
268 days
Submission Type
Summary