Cleared Traditional

EYE IRRIGATOR MODEL #2020

K980647 · Eye-Deal Ocular Safety Products, Inc. · Ophthalmic

May 1998

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K980647 is an FDA 510(k) clearance for the EYE IRRIGATOR MODEL #2020, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Eye-Deal Ocular Safety Products, Inc. (Stillwater, US). The FDA issued a Cleared decision on May 15, 1998, 87 days after receiving the submission on February 17, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number	K980647 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 1998
Decision Date	May 15, 1998
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF