ACUFEX COMPARATIVE SURGICAL KERATOMETER— 510(k) K852424

Name: FDA 510(k) clearance K852424
Creator: U.S. Food and Drug Administration
Published: 1985-09-11

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K852424 for ACUFEX COMPARATIVE SURGICAL KERATOMETER, Substantially Equivalent on 1985-09-11. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HJB
Device class: Class 1
Regulation: 21 CFR 886.1450
Advisory panel: Ophthalmic
Date received: 1985-06-07
Decision date: 1985-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, 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.