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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 K162415
Device Name Spectra 9Plus
Applicant
Uzinmedicare Company
Room 105, Joongang Induspia V, Sagimakgolo 137
Jungwon-gu, Seoungnam-Si
Seoul,  KR 13202
Applicant Contact Nathan Ahn
Correspondent
Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street, N.W., Suite 1200
Washington,  DC  20005
Correspondent Contact Jeffrey K. Shapiro
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/29/2016
Decision Date 03/15/2017
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
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