Cleared Traditional

WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT

K945877 · Wells Johnson Co. · Ophthalmic
Mar 1995
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K945877 is an FDA 510(k) clearance for the WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT, a Transilluminator, Ac-powered (Class II — Special Controls, product code HJM), submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on March 2, 1995, 91 days after receiving the submission on December 1, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1945.

Submission Details

510(k) Number K945877 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1994
Decision Date March 02, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJM — Transilluminator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1945

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