K-number	K983373
Device name	IMPACT BALLOON DILATION CATHETER
Applicant	B. Braun/Mcgaw
Product code	KNQ
Device class	Class II
Decision date	Jun 22, 1999
Decision	Substantially Equivalent
Regulation	876.5365

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Source

View the full FDA submission: accessdata.fda.gov

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IMPACT BALLOON DILATION CATHETER

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