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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
FERTILITY FOCUS LTD
717 lakeglen drive
suwanee,  GA  30024
Original Contact penny northcutt
Classification Product Code
LHD  
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
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