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FDA 510(k)

MASTEL 1 FOLDER IMPLANTATION SYSTEM

K-Number: K022723 · 2002-12-26

ApplicantMastel Precision, Inc.
Decision Date2002-12-26
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MASTEL 1 FOLDER IMPLANTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mastel Precision, Inc.. It received FDA 510(k) clearance on 2002-12-26 under 510(k) number K022723. 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 MASTEL 1 FOLDER IMPLANTATION SYSTEM?

MASTEL 1 FOLDER IMPLANTATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-26. The listed applicant is Mastel Precision, Inc.. The 510(k) number is K022723.

When did MASTEL 1 FOLDER IMPLANTATION SYSTEM receive FDA 510(k) clearance?

MASTEL 1 FOLDER IMPLANTATION SYSTEM received FDA 510(k) clearance on 2002-12-26, under 510(k) number K022723.

Who is the listed applicant for MASTEL 1 FOLDER IMPLANTATION SYSTEM?

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

What is the FDA product code for MASTEL 1 FOLDER IMPLANTATION SYSTEM?

The FDA product code for MASTEL 1 FOLDER IMPLANTATION SYSTEM is KYB.

Related Clinical Trials

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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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