Cleared Traditional

PEREGRINE WIDE ANGLE LIGHT PIPE

K940393 · Peregrine Surgical , Ltd. · Ophthalmic
Sep 1994
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K940393 is an FDA 510(k) clearance for the PEREGRINE WIDE ANGLE LIGHT PIPE, a Transilluminator, Ac-powered (Class II — Special Controls, product code HJM), submitted by Peregrine Surgical , Ltd. (Doylestown, US). The FDA issued a Cleared decision on September 2, 1994, 219 days after receiving the submission on January 26, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1945.

Submission Details

510(k) Number K940393 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1994
Decision Date September 02, 1994
Days to Decision 219 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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