K-number	K131745
Device name	BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
Applicant	Helix Medical, LLC
Product code	LFB
Device class	Class U
Decision date	Sep 17, 2013
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

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