K-number	K944512
Device name	TRUZONE PFM DISPOSABLE MOUTHPIECE
Applicant	Monaghan Medical Corp.
Product code	BYP
Device class	Class I
Decision date	Nov 2, 1994
Decision	Substantially Equivalent
Regulation	868.5620

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View the full FDA submission: accessdata.fda.gov

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TRUZONE PFM DISPOSABLE MOUTHPIECE

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