Last synced on 25 November 2022 at 11:04 pm

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203637
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2022
Days to Decision
449 days
Submission Type
Summary

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203637
510(k) Type
Traditional
Applicant
Coloplast
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2022
Days to Decision
449 days
Submission Type
Summary