KERATOME SYSTEM, MODEL K3000— 510(k) K984537

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.

Clearance details

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

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