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FDA 510(k)

PETRUS IOL GUIDE

K-Number: K840104 · 1984-04-24

ApplicantPrecision-Cosmet Co., Inc.
Decision Date1984-04-24
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PETRUS IOL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Precision-Cosmet Co., Inc.. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K840104. The device is classified under product code KYB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PETRUS IOL GUIDE?

PETRUS IOL GUIDE is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Precision-Cosmet Co., Inc.. The 510(k) number is K840104.

When did PETRUS IOL GUIDE receive FDA 510(k) clearance?

PETRUS IOL GUIDE received FDA 510(k) clearance on 1984-04-24, under 510(k) number K840104.

Who is the listed applicant for PETRUS IOL GUIDE?

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

What is the FDA product code for PETRUS IOL GUIDE?

The FDA product code for PETRUS IOL GUIDE is KYB.

Related Clinical Trials

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.

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Other records listing Precision-Cosmet Co., 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.

K861057MANUAL OPHTHALMIC SURGICAL INSTRUMENTSK852934PRECISION - COSMET CAPSULE COUPEURK840204WHITE OCULAR PRESSURE RELIEF DEVICE

Related Devices (Code: KYB)

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.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.

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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