RETINA CAMERA TRC-NW7SF MARK II— 510(k) K090115

Substantially Equivalent

Topcon Corp.

FDA 510(k) clearance K090115 for RETINA CAMERA TRC-NW7SF MARK II, Substantially Equivalent on 2009-06-30. Applicant: Topcon Corp.. Device class: 2.

Clearance details

Applicant: Topcon Corp.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2009-01-21
Decision date: 2009-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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