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GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152913
510(k) Type
Traditional
Applicant
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
7/21/2016
Days to Decision
293 days
Submission Type
Summary

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152913
510(k) Type
Traditional
Applicant
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
7/21/2016
Days to Decision
293 days
Submission Type
Summary