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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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