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RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140523
510(k) Type
Special
Applicant
COLOPLAST A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/2014
Days to Decision
142 days
Submission Type
Summary

RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140523
510(k) Type
Special
Applicant
COLOPLAST A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/2014
Days to Decision
142 days
Submission Type
Summary