K-number	K924712
Device name	ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Applicant	Hearing Tech, Inc.
Product code	MCW
Device class	Class II
Decision date	Dec 8, 1992
Decision	Substantially Equivalent
Regulation	870.4875

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View the full FDA submission: accessdata.fda.gov

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ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

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