Cleared Traditional

LOCATOR, FOREIGN BODY

K781892 · Keeler Optical Products , Ltd. · Ophthalmic
Dec 1978
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K781892 is an FDA 510(k) clearance for the LOCATOR, FOREIGN BODY, a Locator, Metal, Electronic (Class II — Special Controls, product code HPM), submitted by Keeler Optical Products , Ltd. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978, 26 days after receiving the submission on November 8, 1978. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4400.

Submission Details

510(k) Number K781892 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1978
Decision Date December 04, 1978
Days to Decision 26 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPM — Locator, Metal, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4400