Cleared Traditional

D.O.R.C. HEXON ILLUMINATION SYSTEM

K973229 · Dutch Ophthalmic USA, Inc. · Ophthalmic
Nov 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K973229 is an FDA 510(k) clearance for the D.O.R.C. HEXON ILLUMINATION SYSTEM, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on November 25, 1997, 90 days after receiving the submission on August 27, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K973229 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1997
Decision Date November 25, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MPA — Endoilluminator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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