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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, fertility diagnostic, proceptive
510(k) Number K122337
Device Name OVUSENSE
Original Applicant
717 lakeglen drive
suwanee,  GA  30024
Original Contact penny northcutt
Classification Product Code
Date Received08/02/2012
Decision Date 08/06/2013
Decision substantially equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No