OTI MODEL TLS-60— 510(k) K951437

Substantially Equivalent

Oti Medical, LLC

FDA 510(k) clearance K951437 for OTI MODEL TLS-60, Substantially Equivalent on 1995-04-11. Applicant: Oti Medical, LLC. Device class: 1.

Clearance details

Applicant: Oti Medical, LLC
Product code: Code HPC
Device class: Class 1
Regulation: 21 CFR 886.1405
Advisory panel: Ophthalmic
Date received: 1995-03-27
Decision date: 1995-04-11
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.