K-number	K053188
Device name	REPROCESSED BALOON INFLATION DEVICE
Applicant	Sterilmed, Inc.
Product code	NKU
Device class	Class II
Decision date	May 4, 2006
Decision	Substantially Equivalent
Regulation	870.1650

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View the full FDA submission: accessdata.fda.gov

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REPROCESSED BALOON INFLATION DEVICE

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