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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 K142168
Device Name NATURE'S BOND 600 AND NATURE'S BOND 603
Applicant
Devon Medical Products, Inc.
1100 First Ave., Suite 202
King Of Prussia,  PA  19406
Applicant Contact Ruth Wu
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/06/2014
Decision Date 12/04/2014
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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