K-number	K112322
Device name	RESTORELLE POLYPROPYLENE Y MESH
Applicant	Coloplast A/S
Product code	OTO
Device class	Class II
Decision date	May 17, 2012
Decision	Substantially Equivalent
Regulation	878.3300

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View the full FDA submission: accessdata.fda.gov

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RESTORELLE POLYPROPYLENE Y MESH

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