K-number	K122067
Device name	TYPE 1077 ACCUSCREEN
Applicant	Gn Otometrics
Product code	GWJ
Device class	Class II
Decision date	Sep 27, 2012
Decision	Substantially Equivalent
Regulation	882.1900

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View the full FDA submission: accessdata.fda.gov

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TYPE 1077 ACCUSCREEN

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