FDA 510(k) K100662, FEMVUE CORNUAL BALLOON CATHETER, by Femasys, Inc.

FDA 510(k) K100662, FEMVUE CORNUAL BALLOON CATHETER, by Femasys, Inc.

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Device Classification Name: Cannula, Manipulator/Injector, Uterine
510(k) Number: K100662
Device Name: FEMVUE CORNUAL BALLOON CATHETER
Applicant: Femasys, Inc.
Regulation Number: 884.4530
Classification Product Code: LKF
Date Received: 03/08/2010
Decision Date: 04/07/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
510k Review Panel: Obstetrics/Gynecology

Total number of pages: 105
Fully redacted pages: 14
Content pages: 91

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