FDA.report

510(k) K231786

Device
Gynethotics? Pessary
Applicant
Cosm Medical
510(k) number
K231786
Product code
HHW
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-06
Date received
2023-06-20
Regulation
884.3575
Classification name
Pessary, Vaginal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Linda Wu
Address
101 College St. Toronto CA M5G1L7 M5G1L7

FDA Registration Numbers

Source Documents

510(k) summary PDF

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