K-number	K102971
Device name	FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
Applicant	Microtek Medical, Inc.
Product code	FYA
Device class	Class II
Decision date	Feb 23, 2011
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

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