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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 K191208
Device Name Spectra Cashmere
Applicant
Uzinmedicare Co.
56, Dongtansandan 5-Gil,Dongtan-Myeon
Hwaseong-Si,  KR 18487
Applicant Contact Nathan Ahn
Correspondent
Hyman, Phelps & McNamara, PC
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Adrienne R. Lenz
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/06/2019
Decision Date 10/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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