KERATOME SYSTEM— 510(k) K974243

Name: FDA 510(k) clearance K974243
Creator: U.S. Food and Drug Administration
Published: 1998-01-20

Substantially Equivalent

Insight Technologies Instruments, LLC

FDA 510(k) clearance K974243 for KERATOME SYSTEM, Substantially Equivalent on 1998-01-20. 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: 1997-11-12
Decision date: 1998-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

Download summary PDF View on FDA.gov ↗

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