MODEL 2000 INTRAOPERATIVE CORNEASCOPE— 510(k) K901009

Name: FDA 510(k) clearance K901009
Creator: U.S. Food and Drug Administration
Published: 1990-05-30

Substantially Equivalent

Kera Corp.

FDA 510(k) clearance K901009 for MODEL 2000 INTRAOPERATIVE CORNEASCOPE, Substantially Equivalent on 1990-05-30. Applicant: Kera Corp.. Device class: 1.

Clearance details

Applicant: Kera Corp.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1990-03-05
Decision date: 1990-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, 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.