K-number	K023670
Device name	SINGLE USE ORAL MASK, MODEL HC455A
Applicant	Fisher & Paykel Healthcare, Ltd.
Product code	BZD
Device class	Class II
Decision date	Jun 12, 2003
Decision	Substantially Equivalent
Regulation	868.5905

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View the full FDA submission: accessdata.fda.gov

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SINGLE USE ORAL MASK, MODEL HC455A

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