K-number	DEN150038
Device name	CleanCisionTM Wound Retraction and Protection System
Applicant	Prescient Surgical
Product code	PQI
Device class	Class II
Decision date	Dec 16, 2016
Decision	Not Substantially Equivalent
Regulation	878.4371

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Source

View the full FDA submission: accessdata.fda.gov

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CleanCisionTM Wound Retraction and Protection System

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