OTI MODEL 78-60— 510(k) K951184

Substantially Equivalent

Oti Medical, LLC

FDA 510(k) clearance K951184 for OTI MODEL 78-60, Substantially Equivalent on 1995-05-12. Applicant: Oti Medical, LLC. Device class: 2.

Clearance details

Applicant: Oti Medical, LLC
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 1995-03-16
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.