K-number	K933367
Device name	GORE-TEX FACIAL IMPLANT
Applicant	W. L. Gore & Associates, Inc.
Product code	FWP
Device class	Class II
Decision date	Jul 28, 1994
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	878.3550

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View the full FDA submission: accessdata.fda.gov

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GORE-TEX FACIAL IMPLANT

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