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NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153479
510(k) Type
Traditional
Applicant
NINEPOINT MEDICAL, INC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/16/2016
Days to Decision
76 days
Submission Type
Summary

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153479
510(k) Type
Traditional
Applicant
NINEPOINT MEDICAL, INC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
2/16/2016
Days to Decision
76 days
Submission Type
Summary