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FDA 510(k)

KLAAS IOL LENSFOLDER

K-Number: K930628 · 1995-02-07

ApplicantBova Intl.
Decision Date1995-02-07
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KLAAS IOL LENSFOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Bova Intl.. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K930628. 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 KLAAS IOL LENSFOLDER?

KLAAS IOL LENSFOLDER is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Bova Intl.. The 510(k) number is K930628.

When did KLAAS IOL LENSFOLDER receive FDA 510(k) clearance?

KLAAS IOL LENSFOLDER received FDA 510(k) clearance on 1995-02-07, under 510(k) number K930628.

Who is the listed applicant for KLAAS IOL LENSFOLDER?

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

What is the FDA product code for KLAAS IOL LENSFOLDER?

The FDA product code for KLAAS IOL LENSFOLDER is KYB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bova Intl. 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.

K930575KAMPPETER ANOMALOSCOPE

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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