TITANIUM OSSICULAR REPLACMENT SYSTEM— 510(k) K030492

Substantially Equivalent

Invotec International, Inc.

FDA 510(k) clearance K030492 for TITANIUM OSSICULAR REPLACMENT SYSTEM, Substantially Equivalent on 2003-03-03. Applicant: Invotec International, Inc.. Device class: 2.

Clearance details

Applicant
Invotec International, Inc.
Product code
Code ETA
Device class
Class 2
Regulation
21 CFR 874.3495
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jacksonville, FL, US
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