K-number	K171181
Device name	PROCOTYL® PRIME E-CLASS XLPE Liner
Applicant	Microport Orthopedics, Inc.
Product code	LZO
Device class	Class II
Decision date	Aug 28, 2017
Decision	Substantially Equivalent
Regulation	888.3353

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Source

View the full FDA submission: accessdata.fda.gov

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PROCOTYL® PRIME E-CLASS XLPE Liner

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PROCOTYL® PRIME E-CLASS XLPE Liner