FDA 510(k), K150476, Spectra S1Plus and Spectra S2 Plus

FDA 510(k), K150476, Spectra S1Plus and Spectra S2 Plus

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510(K) Number: K150476
Device Name: Spectra S1Plus and Spectra S2 Plus
Manufacturer: UZINMEDICARE CO.
Device Classification Name: pump, breast, powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 02/24/2015
Decision Date: 04/15/2016
Regulation Medical Specialty: Obstetrics/Gynecology

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