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Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152342
510(k) Type
Traditional
Applicant
ST. JUDE MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/9/2016
Days to Decision
295 days
Submission Type
Summary

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152342
510(k) Type
Traditional
Applicant
ST. JUDE MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/9/2016
Days to Decision
295 days
Submission Type
Summary