K-number	K213396
Device name	SPIFE A1AT kit
Applicant	Helena Laboratories, Corp.
Product code	OBZ
Device class	Class II
Decision date	Oct 13, 2022
Decision	Substantially Equivalent
Regulation	866.5130

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Source

View the full FDA submission: accessdata.fda.gov

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SPIFE A1AT kit

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