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Gynescope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190187
510(k) Type
Traditional
Applicant
Illumigyn Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
5/8/2019
Days to Decision
96 days
Submission Type
Summary

Gynescope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190187
510(k) Type
Traditional
Applicant
Illumigyn Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
5/8/2019
Days to Decision
96 days
Submission Type
Summary