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i-CAT FLX V series / KaVo 3D eXam+ V series

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162085
510(k) Type
Traditional
Applicant
IMAGING SCIENCES INTERNATIONAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/10/2016
Days to Decision
106 days
Submission Type
Summary

i-CAT FLX V series / KaVo 3D eXam+ V series

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162085
510(k) Type
Traditional
Applicant
IMAGING SCIENCES INTERNATIONAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/10/2016
Days to Decision
106 days
Submission Type
Summary