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BI-FLEX URETERAL ACCESS SHEATH

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140441
510(k) Type
Traditional
Applicant
PROMEPLA SAM
Country
Monaco
FDA Decision
Substantially Equivalent
Decision Date
6/17/2014
Days to Decision
116 days
Submission Type
Summary

BI-FLEX URETERAL ACCESS SHEATH

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140441
510(k) Type
Traditional
Applicant
PROMEPLA SAM
Country
Monaco
FDA Decision
Substantially Equivalent
Decision Date
6/17/2014
Days to Decision
116 days
Submission Type
Summary