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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
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 Number884.6110
Classification Product Code
MQF  
Date Received06/13/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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