K-number	K112386
Device name	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Applicant	Coloplast Corp.
Product code	OTP
Device class	Class III
Decision date	Sep 8, 2011
Decision	Substantially Equivalent
Regulation	884.5980

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View the full FDA submission: accessdata.fda.gov

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EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

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