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Sonata Transcervical Fibroid Ablation System 2.2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211535
510(k) Type
Special
Applicant
Gynesonics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/17/2021
Days to Decision
30 days
Submission Type
Summary

Sonata Transcervical Fibroid Ablation System 2.2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211535
510(k) Type
Special
Applicant
Gynesonics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/17/2021
Days to Decision
30 days
Submission Type
Summary