Name: Predicase
Price: 199 USD

K-number	K130354
Device name	MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
Applicant	Entrigue Surgical, Inc.
Product code	LYA
Device class	Class I
Decision date	May 29, 2013
Decision	Substantially Equivalent
Regulation	874.4780

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Source

View the full FDA submission: accessdata.fda.gov

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MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)

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