Cleared Traditional

EMERGENCY POWER PAC (EMPAC)

K813273 · Optical Micro Systems, Inc. · Ophthalmic

Dec 1981

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K813273 is an FDA 510(k) clearance for the EMERGENCY POWER PAC (EMPAC), a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981, 41 days after receiving the submission on November 20, 1981. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K813273 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 1981
Decision Date	December 31, 1981
Days to Decision	41 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