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PENTAX Medical ENT Video Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162151
510(k) Type
Traditional
Applicant
PENTAX OF AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/20/2017
Days to Decision
261 days
Submission Type
Summary

PENTAX Medical ENT Video Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162151
510(k) Type
Traditional
Applicant
PENTAX OF AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/20/2017
Days to Decision
261 days
Submission Type
Summary