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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name perineometer
510(k) Number K121902
Model 1
Device Name NATRATONE
Original Applicant
ORELLE CORPORATION LTD
4739 - 44th ave s.w., unit 403
seattle,  WA  98116
Original Contact patricia coombes
Regulation Number884.1425
Classification Product Code
HIR  
Date Received07/16/2012
Decision Date 06/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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