Cleared Traditional

KEATES I/A SYSTEM FRIGITRONICS 4000

K822599 · Frigitronics of Connecticut, Inc. · Ophthalmic

Oct 1982

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K822599 is an FDA 510(k) clearance for the KEATES I/A SYSTEM FRIGITRONICS 4000, a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by Frigitronics of Connecticut, Inc. (Walker, US). The FDA issued a Cleared decision on October 6, 1982, 40 days after receiving the submission on August 27, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K822599 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 1982
Decision Date	October 06, 1982
Days to Decision	40 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