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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K110993
Device Name FEMCHEC PRESSURE MANAGEMET DEVICE
Applicant
FEMASYS INC.
5000 RESEARCH COURT STE .100
SUWANEE,  GA  30024
Applicant Contact LISA PEACOCK
Correspondent
FEMASYS INC.
5000 RESEARCH COURT STE .100
SUWANEE,  GA  30024
Correspondent Contact LISA PEACOCK
Regulation Number884.4530
Classification Product Code
LKF  
Date Received04/08/2011
Decision Date 10/12/2011
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
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