Name: Predicase
Price: 199 USD

K-number	K051067
Device name	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
Applicant	LeMaitre Vascular, Inc.
Product code	MJN
Device class	Class II
Decision date	May 27, 2005
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)

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