K-number	K083499
Device name	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
Applicant	Coloplast A/S
Product code	OTP
Device class	Class III
Decision date	May 8, 2009
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 SYSTEMS

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