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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
Models PERSONAL SENSOR: M011, READER: M010, STARTER PACK (PERSONAL SENSOR AND READER) ADVANCED FERTILITY MONITORING SYSTEM): M009
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 (SE)
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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