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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, breast, powered
510(k) Number K121322
Device Name CLOSER TO NATURE
Original Applicant
MAYBORN GROUP LIMITED
dudley lane
cramlington
northumberlan,  UK ne23 trh
Original Contact neil hewitt
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/02/2012
Decision Date 05/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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