AUTOMATED CORNEAL TREPHINE— 510(k) K981063

Name: FDA 510(k) clearance K981063
Creator: U.S. Food and Drug Administration
Published: 1998-06-23

Substantially Equivalent

Laser Center Dev. Corp.

FDA 510(k) clearance K981063 for AUTOMATED CORNEAL TREPHINE, Substantially Equivalent on 1998-06-23. Applicant: Laser Center Dev. Corp.. Device class: 1.

Clearance details

Applicant: Laser Center Dev. Corp.
Product code: Code HRG
Device class: Class 1
Regulation: 21 CFR 886.4070
Advisory panel: Ophthalmic
Date received: 1998-03-23
Decision date: 1998-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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