OTOMIMIX— 510(k) K042516

Substantially Equivalent

Walter Lorenz Surgical, Inc.

FDA 510(k) clearance K042516 for OTOMIMIX, Substantially Equivalent on 2004-11-08. Applicant: Walter Lorenz Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Walter Lorenz Surgical, Inc.
Product code: Code NEA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2004-09-16
Decision date: 2004-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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