K-number	K150729
Device name	SpectraShield 9500 Surgical N95 Respirator
Applicant	Nexera Medical, Inc.
Product code	ONT
Device class	Class II
Decision date	Dec 29, 2015
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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SpectraShield 9500 Surgical N95 Respirator

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