K-number	K160100
Device name	Prestige Ameritech Pediatric/Childs Face mask
Applicant	Prestige Ameritech
Product code	OXZ
Device class	Class II
Decision date	Oct 7, 2016
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Prestige Ameritech Pediatric/Childs Face mask

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Prestige Ameritech Pediatric/Childs Face mask