Femasys Inc (FEMY)

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Femasys (FEMY) receives FDA 510(k) clearance for FemaSeed
PR is imminent, probably Tuesday. Low float and low volume stock, trade carefully.

510(k) Number K231730
Device Name FemaSeed Intratubal Insemination
Applicant
Femasys Inc.
3950 Johns Creek CT.
Suwanee, GA 30024
Applicant Contact Christine Thomas
Correspondent
Femasys Inc.
3950 Johns Creek CT.
Suwanee, GA 30024
Correspondent Contact Christine Thomas
Regulation Number 884.6110
Classification Product Code
MQF
Date Received 06/13/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No