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FDA 510(k)

OMS INFUSION-ASPIRATION HANDLE

K-Number: K813500 · 1982-02-04

ApplicantOptical Micro Systems, Inc.
Decision Date1982-02-04
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OMS INFUSION-ASPIRATION HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K813500. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMS INFUSION-ASPIRATION HANDLE?

OMS INFUSION-ASPIRATION HANDLE is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K813500.

When did OMS INFUSION-ASPIRATION HANDLE receive FDA 510(k) clearance?

OMS INFUSION-ASPIRATION HANDLE received FDA 510(k) clearance on 1982-02-04, under 510(k) number K813500.

Who is the listed applicant for OMS INFUSION-ASPIRATION HANDLE?

The FDA 510(k) record lists Optical Micro Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMS INFUSION-ASPIRATION HANDLE?

The FDA product code for OMS INFUSION-ASPIRATION HANDLE is HQE.

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Other records listing Optical Micro Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950218OMS SLIMLINE PHACO HANDPIECEK946054DIPLOMAXK935223OPHTHALMIC SURGICAL SYSTEMK935226I/V POLEK935003ELECTRIC I/V POLE OR EIVP2K870068ASPIRATION REVERSAL CONTROL (ARC) MODULE

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Related Devices (Code: HQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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