MENTOR GEMINI HEMOSTATIC ERASER— 510(k) K971538

Name: FDA 510(k) clearance K971538
Creator: U.S. Food and Drug Administration
Published: 1997-07-14

Substantially Equivalent

Mentor Ophthalmics, Inc.

FDA 510(k) clearance K971538 for MENTOR GEMINI HEMOSTATIC ERASER, Substantially Equivalent on 1997-07-14. Applicant: Mentor Ophthalmics, Inc.. Device class: 2.

Clearance details

Applicant: Mentor Ophthalmics, Inc.
Product code: Code HQO
Device class: Class 2
Regulation: 21 CFR 886.4115
Advisory panel: Ophthalmic
Date received: 1997-04-28
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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