• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K181784, Spectra S3 Plus, by Uzinmedicare Co.

FDA 510(k) K181784, Spectra S3 Plus, by Uzinmedicare Co.

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510(K) Number: K181784
Device Name: Spectra S3 Plus
Manufacturer: Uzinmedicare Co.
Device Classification Name: pump, breast, powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 07/03/2018
Decision Date: 11/30/2018
Regulation Medical Specialty: Obstetrics/Gynecology

220 pages (611 of 831 original pages are fully redacted)
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