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THE GYNOCULAR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K132423
510(k) Type
Traditional
Applicant
GYNIUS AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
4/8/2014
Days to Decision
246 days
Submission Type
Summary

THE GYNOCULAR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K132423
510(k) Type
Traditional
Applicant
GYNIUS AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
4/8/2014
Days to Decision
246 days
Submission Type
Summary