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FDA 510(k)

KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR

K-Number: K870265 · 1987-02-20

ApplicantCooperVision, Inc.
Decision Date1987-02-20
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1987-02-20 under 510(k) number K870265. 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 KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR?

KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR is a medical device that received FDA 510(k) clearance on 1987-02-20. The listed applicant is CooperVision, Inc.. The 510(k) number is K870265.

When did KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR receive FDA 510(k) clearance?

KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR received FDA 510(k) clearance on 1987-02-20, under 510(k) number K870265.

Who is the listed applicant for KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR?

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

What is the FDA product code for KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR?

The FDA product code for KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR is KYB.

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Other records listing CooperVision, 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.

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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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