Cleared Traditional

K874252 - KREDA DISC
(FDA 510(k) Clearance)

K874252 · Richmond Products, Inc. · Ophthalmic device

Jan 1988

Decision

100d

Days

Class 1

Risk

K874252 is an FDA 510(k) clearance for the KREDA DISC. This device is classified as a Grid, Amsler (Class I - General Controls, product code HOQ).

Submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 27, 1988, 100 days after receiving the submission on October 19, 1987.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1330.

Submission Details

510(k) Number	K874252 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 19, 1987
Decision Date	January 27, 1988
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—