Cleared Traditional

RARE EARTH INTRA-OCULAR MAGNET

K860960 · Ameritek, Inc. · Ophthalmic

Mar 1986

Decision

18d

Days

Class 1

Risk

About This 510(k) Submission

K860960 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 Ameritek, Inc. (Miami, US). The FDA issued a Cleared decision on March 31, 1986, 18 days after receiving the submission on March 13, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4445.

Submission Details

510(k) Number	K860960 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 1986
Decision Date	March 31, 1986
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—