Name: Predicase
Price: 199 USD

K-number	K151368
Device name	Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
Applicant	Terumo Bct
Product code	LKN
Device class	Class U
Decision date	Sep 11, 2015
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter

Everything you need for a 510(k) submission. Nothing you don't.