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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
Applicant
Mayborn Group Limited
Dudley Lane
Cramlington
Northumberlan,  GB NE23 TRH
Applicant Contact NEIL HEWITT
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/02/2012
Decision Date 05/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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