K-number	K161110
Device name	ClearPetra Suction-Evacuation Sheath
Applicant	Well Lead Medical Co., Ltd.
Product code	FED
Device class	Class II
Decision date	Oct 12, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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ClearPetra Suction-Evacuation Sheath

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