K-number	K153138
Device name	Cerdak Basic
Applicant	Bu Polysciences Equipment & Trading, LLC
Product code	FRO
Device class	Class U
Decision date	Jun 23, 2017
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Cerdak Basic

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