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FDA 510(k)

MONARCH IOL DELIVERY SYSTEM

K-Number: K970033 · 1997-04-23

ApplicantAlcon Laboratories
Decision Date1997-04-23
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MONARCH IOL DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K970033. 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 MONARCH IOL DELIVERY SYSTEM?

MONARCH IOL DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Alcon Laboratories. The 510(k) number is K970033.

When did MONARCH IOL DELIVERY SYSTEM receive FDA 510(k) clearance?

MONARCH IOL DELIVERY SYSTEM received FDA 510(k) clearance on 1997-04-23, under 510(k) number K970033.

Who is the listed applicant for MONARCH IOL DELIVERY SYSTEM?

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

What is the FDA product code for MONARCH IOL DELIVERY SYSTEM?

The FDA product code for MONARCH IOL DELIVERY SYSTEM is KYB.

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Other records listing Alcon Laboratories 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.

K062624NEXT GENERATION LASERK062865SMALL VOLUME SYRINGEK000148RGP MULTI-PURPOSE SOLUTION ID 100136K984573OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROPK990480OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVERK984575MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

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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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