Cleared Traditional

ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)

K880647 · Fred Sammons, Inc. · Ophthalmic
Apr 1988
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K880647 is an FDA 510(k) clearance for the ADULT PERCEPTUAL MOTOR PUZZLES (5331-01), a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Fred Sammons, Inc. (Burr Ridge, US). The FDA issued a Cleared decision on April 1, 1988, 45 days after receiving the submission on February 16, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K880647 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1988
Decision Date April 01, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HOX — Chart, Visual Acuity
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1150

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