Cleared Traditional

MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50

K854440 · Keeler Instruments, Inc. · General & Plastic Surgery
Dec 1985
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K854440 is an FDA 510(k) clearance for the MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50, a Microscope, Operating & Accessories, Ac-powered, Ophthalmic (Class I — General Controls, product code HRM), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 16, 1985, 41 days after receiving the submission on November 5, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4700.

Submission Details

510(k) Number K854440 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1985
Decision Date December 16, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HRM — Microscope, Operating & Accessories, Ac-powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4700

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