Cleared Traditional

EYE-VAC

K801231 · Coburn Optical Ind., Inc. · Ophthalmic

Jul 1980

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K801231 is an FDA 510(k) clearance for the EYE-VAC, a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980, 55 days after receiving the submission on May 27, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K801231 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 1980
Decision Date	July 21, 1980
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—

Device Classification

Product Code	HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4150