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Foley Balloon Catheter for Urology

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201776
510(k) Type
Traditional
Applicant
Apollon co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/30/2020
Days to Decision
184 days
Submission Type
Summary

Foley Balloon Catheter for Urology

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201776
510(k) Type
Traditional
Applicant
Apollon co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/30/2020
Days to Decision
184 days
Submission Type
Summary