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SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151536
510(k) Type
Special
Applicant
MRI INTERVENTIONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/8/2015
Days to Decision
30 days
Submission Type
Summary

SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151536
510(k) Type
Special
Applicant
MRI INTERVENTIONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/8/2015
Days to Decision
30 days
Submission Type
Summary