Name: Predicase
Price: 199 USD

K-number	K040996
Device name	RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
Applicant	Gyrus Ent LLC
Product code	NIX
Device class	Class II
Decision date	Aug 20, 2004
Decision	Substantially Equivalent
Regulation	874.3950

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View the full FDA submission: accessdata.fda.gov

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RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM

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