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FDA 510(k)

DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE

K-Number: K912384 · 1991-12-24

ApplicantNidek, Inc.
Decision Date1991-12-24
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1991-12-24 under 510(k) number K912384. 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 DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE?

DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE is a medical device that received FDA 510(k) clearance on 1991-12-24. The listed applicant is Nidek, Inc.. The 510(k) number is K912384.

When did DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE receive FDA 510(k) clearance?

DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE received FDA 510(k) clearance on 1991-12-24, under 510(k) number K912384.

Who is the listed applicant for DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE?

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

What is the FDA product code for DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE?

The FDA product code for DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE is HQE.

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Other records listing Nidek, Inc. as applicant

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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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