Cleared Traditional

RARE-EARTH INTRA-OCULAR MAGNET

K831702 · Miami Eye Technology, Inc. · Ophthalmic
Jun 1983
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K831702 is an FDA 510(k) clearance for the RARE-EARTH INTRA-OCULAR MAGNET, a Magnet, Permanent (Class I — General Controls, product code HPN), submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983, 36 days after receiving the submission on May 25, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4445.

Submission Details

510(k) Number K831702 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 1983
Decision Date June 30, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPN — Magnet, Permanent
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4445