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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 K100662
Device Name FEMVUE CORNUAL BALLOON CATHETER
Applicant
Femasys, Inc.
5000 Research Court, Suite 100
Suwanee,  GA  30024
Applicant Contact LISA PEACOCK
Correspondent
Femasys, Inc.
5000 Research Court, Suite 100
Suwanee,  GA  30024
Correspondent Contact LISA PEACOCK
Regulation Number884.4530
Classification Product Code
LKF  
Date Received03/08/2010
Decision Date 04/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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