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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, P.C.
700 Thirteenth Street, 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
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