Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EYE ARTIFICIAL CUSTOM

K-Number: K904962 · 1991-08-30

ApplicantMidwest Eye Laboratories, Inc.
Decision Date1991-08-30
Product CodeHQH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE ARTIFICIAL CUSTOM is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Eye Laboratories, Inc.. It received FDA 510(k) clearance on 1991-08-30 under 510(k) number K904962. The device is classified under product code HQH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE ARTIFICIAL CUSTOM?

EYE ARTIFICIAL CUSTOM is a medical device that received FDA 510(k) clearance on 1991-08-30. The listed applicant is Midwest Eye Laboratories, Inc.. The 510(k) number is K904962.

When did EYE ARTIFICIAL CUSTOM receive FDA 510(k) clearance?

EYE ARTIFICIAL CUSTOM received FDA 510(k) clearance on 1991-08-30, under 510(k) number K904962.

Who is the listed applicant for EYE ARTIFICIAL CUSTOM?

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

What is the FDA product code for EYE ARTIFICIAL CUSTOM?

The FDA product code for EYE ARTIFICIAL CUSTOM is HQH.

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 Midwest Eye Laboratories, 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.

K904961ARTIFICIAL SCLERAL SHELL

Related Devices (Code: HQH)

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.

K952538ROBERT B. SCOTT PLASTIC ARTIFICALRobert B. Scott Ocularists of Florida, Inc.K945270CUSTOM ARTIFICIAL HUMAN EYESDaniel T AcostaK946226CUSTOM OCULAR PROSTHESISFrank Tanaka, Ocularist, Inc.K923167THE NISSEL ARTIFICIAL EYENissel , Ltd.K791923SCLERAL POWDEROcularists , Ltd.

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.

↑