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FDA 510(k)

BARTELL SMALL INCISION LENS GLIDE

K-Number: K854994 · 1986-02-04

ApplicantMicrotech, Inc.
Decision Date1986-02-04
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BARTELL SMALL INCISION LENS GLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Microtech, Inc.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K854994. 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 BARTELL SMALL INCISION LENS GLIDE?

BARTELL SMALL INCISION LENS GLIDE is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Microtech, Inc.. The 510(k) number is K854994.

When did BARTELL SMALL INCISION LENS GLIDE receive FDA 510(k) clearance?

BARTELL SMALL INCISION LENS GLIDE received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854994.

Who is the listed applicant for BARTELL SMALL INCISION LENS GLIDE?

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

What is the FDA product code for BARTELL SMALL INCISION LENS GLIDE?

The FDA product code for BARTELL SMALL INCISION LENS GLIDE is KYB.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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