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ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190744
510(k) Type
Special
Applicant
Olympus Winter & Ibe GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
8/29/2019
Days to Decision
160 days
Submission Type
Summary

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190744
510(k) Type
Special
Applicant
Olympus Winter & Ibe GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
8/29/2019
Days to Decision
160 days
Submission Type
Summary