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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 K150476
Device Name Spectra S1Plus and Spectra S2 Plus
Applicant
Uzinmedicare Co.
Rm.105, Joongang Induspia V, Sagimakgolo 137
Jungwon-Gu,  KR 462-807
Applicant Contact Ho Jun Kang
Correspondent
Onbix Corporation
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Charlene Cho
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/24/2015
Decision Date 04/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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