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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
Rm 105, Joongang Induspia V, Sagimakgolo 137
Jungwon-gu,  KR 462-807
Applicant Contact Ho Jun Kang
Onbix Corporation
700 Thirteenth Street, N.W.
Suite 1200
Washington,  DC  20005
Correspondent Contact Charlene Cho
Regulation Number884.5160
Classification Product Code
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