K-number	K001736
Device name	GALEO HYDRO AND GALEO HYDRO J-TIP
Applicant	Biotronik, Inc.
Product code	DQX
Device class	Class II
Decision date	Aug 2, 2000
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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GALEO HYDRO AND GALEO HYDRO J-TIP

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