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SpeediCath Flex Coude

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161672
510(k) Type
Traditional
Applicant
Coloplast Corp.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2016
Days to Decision
112 days
Submission Type
Summary

SpeediCath Flex Coude

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161672
510(k) Type
Traditional
Applicant
Coloplast Corp.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2016
Days to Decision
112 days
Submission Type
Summary