K-number	K182006
Device name	Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
Applicant	Hologic, Inc.
Product code	HIH
Device class	Class II
Decision date	Dec 6, 2018
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

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