EYE FIXATION SPECULUM— 510(k) K964289

Substantially Equivalent

Eyefix, Inc.

FDA 510(k) clearance K964289 for EYE FIXATION SPECULUM, Substantially Equivalent on 1996-12-17. Applicant: Eyefix, Inc.. Device class: 1.

Clearance details

Applicant: Eyefix, Inc.
Product code: Code HNC
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1996-10-28
Decision date: 1996-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.