K-number	K112456
Device name	ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
Applicant	Teleflexmedical, Inc.
Product code	GCJ
Device class	Class II
Decision date	Oct 4, 2011
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT

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