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FDA 510(k)

MAZZOCCO/FRENCHIK FOLDER

K-Number: K860148 · 1986-03-21

ApplicantStaar Surgical Co.
Decision Date1986-03-21
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAZZOCCO/FRENCHIK FOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Staar Surgical Co.. It received FDA 510(k) clearance on 1986-03-21 under 510(k) number K860148. 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 MAZZOCCO/FRENCHIK FOLDER?

MAZZOCCO/FRENCHIK FOLDER is a medical device that received FDA 510(k) clearance on 1986-03-21. The listed applicant is Staar Surgical Co.. The 510(k) number is K860148.

When did MAZZOCCO/FRENCHIK FOLDER receive FDA 510(k) clearance?

MAZZOCCO/FRENCHIK FOLDER received FDA 510(k) clearance on 1986-03-21, under 510(k) number K860148.

Who is the listed applicant for MAZZOCCO/FRENCHIK FOLDER?

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

What is the FDA product code for MAZZOCCO/FRENCHIK FOLDER?

The FDA product code for MAZZOCCO/FRENCHIK FOLDER is KYB.

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Other records listing Staar Surgical Co. 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.

K090161EPIPHANY INJECTION SYSTEMK073586MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEMK073591MICROSTAAR MSI INJECTOR FOAM TIP SYSTEMK032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SK020734SURGE-FREE ASPIRATION ADAPTERK983129DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)

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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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