MENTOR TONO-PEN 3— 510(k) K964312

Substantially Equivalent

Mentor Ophthalmics, Inc.

FDA 510(k) clearance K964312 for MENTOR TONO-PEN 3, Substantially Equivalent on 1996-11-26. Applicant: Mentor Ophthalmics, Inc.. Device class: 2.

Clearance details

Applicant: Mentor Ophthalmics, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 1996-10-29
Decision date: 1996-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mentor Ophthalmics, Inc.

K973146 — MENTOR SUPER ABSORBENT DRAPE1997-12-04
K971538 — MENTOR GEMINI HEMOSTATIC ERASER1997-07-14
K960765 — MENTOR ADVENT A/B SYSTEM1996-08-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.