Cleared Traditional

SEBESTYEN IRRIGATING CONTACT LENS

K802927 · Cooper Medical Devices Corp. · Ophthalmic
Feb 1981
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K802927 is an FDA 510(k) clearance for the SEBESTYEN IRRIGATING CONTACT LENS, a Lens, Fundus, Hruby, Diagnostic (Class I — General Controls, product code HJI), submitted by Cooper Medical Devices Corp. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1981, 78 days after receiving the submission on November 19, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1395.

Submission Details

510(k) Number K802927 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1980
Decision Date February 05, 1981
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HJI — Lens, Fundus, Hruby, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1395