Name: Predicase
Price: 199 USD

K-number	K091011
Device name	PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
Applicant	Surgical Technology Laboratories, Inc ("Stl")
Product code	FWP
Device class	Class II
Decision date	Apr 22, 2009
Decision	Substantially Equivalent
Regulation	878.3550

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Source

View the full FDA submission: accessdata.fda.gov

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PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)

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