K-number	K142477
Device name	Intact Advance and Intact Excision XL, Intact BLES
Applicant	Intact Medical Corporation
Product code	KNW
Device class	Class II
Decision date	Dec 15, 2014
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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Intact Advance and Intact Excision XL, Intact BLES

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