Cleared Traditional

SHADOW MEDAL LOCATOR

K953277 · Fatswith Intl., Inc. · Ophthalmic
Apr 1996
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K953277 is an FDA 510(k) clearance for the SHADOW MEDAL LOCATOR, a Locator, Metal, Electronic (Class II — Special Controls, product code HPM), submitted by Fatswith Intl., Inc. (Vancouver, Bc,, CA). The FDA issued a Cleared decision on April 1, 1996, 263 days after receiving the submission on July 13, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4400.

Submission Details

510(k) Number K953277 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1995
Decision Date April 01, 1996
Days to Decision 263 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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