Cleared Traditional

SURGICAL/LID MARGIN COVER & EYELASH-

K831285 · Richard R. Anthony, M.D. · Ophthalmic
Jun 1983
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K831285 is an FDA 510(k) clearance for the SURGICAL/LID MARGIN COVER & EYELASH-, a Clamp, Eyelid, Ophthalmic (Class I — General Controls, product code HOD), submitted by Richard R. Anthony, M.D. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983, 44 days after receiving the submission on April 20, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K831285 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1983
Decision Date June 03, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HOD — Clamp, Eyelid, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350