KERATOME SYSTEM, MODEL K3000— 510(k) K984537

Name: FDA 510(k) clearance K984537
Creator: U.S. Food and Drug Administration
Published: 1999-05-14

Substantially Equivalent

Insight Technologies Instruments, LLC

FDA 510(k) clearance K984537 for KERATOME SYSTEM, MODEL K3000, Substantially Equivalent on 1999-05-14. Applicant: Insight Technologies Instruments, LLC. Device class: 1.

Clearance details

Applicant: Insight Technologies Instruments, LLC
Product code: Code HMY
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 1998-12-21
Decision date: 1999-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

Download summary PDF View on FDA.gov ↗

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