K-number	K123561
Device name	ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
Applicant	Bsn Medical, Inc.
Product code	DWL
Device class	Class II
Decision date	Dec 18, 2012
Decision	Substantially Equivalent
Regulation	880.5780

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Source

View the full FDA submission: accessdata.fda.gov

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ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

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