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Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173657
510(k) Type
Traditional
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/23/2018
Days to Decision
267 days
Submission Type
Summary

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173657
510(k) Type
Traditional
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/23/2018
Days to Decision
267 days
Submission Type
Summary