K-number	K091613
Device name	TAKE 1
Applicant	Kerr Corp.
Product code	ELW
Device class	Class II
Decision date	Oct 7, 2009
Decision	Substantially Equivalent
Regulation	872.3660

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Source

View the full FDA submission: accessdata.fda.gov

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TAKE 1

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