K-number	K180135
Device name	THD Anopress with THD SensyProbe
Applicant	Thd Spa
Product code	KLA
Device class	Class II
Decision date	Mar 8, 2018
Decision	Substantially Equivalent
Regulation	876.1725

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Source

View the full FDA submission: accessdata.fda.gov

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THD Anopress with THD SensyProbe

Everything you need for a 510(k) submission. Nothing you don't.