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FDA 510(k)

MEDILENS(TM) CORNEAL SHIELD

K-Number: K901880 · 1990-07-02

ApplicantChiron Ophthalmics
Decision Date1990-07-02
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MEDILENS(TM) CORNEAL SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Ophthalmics. It received FDA 510(k) clearance on 1990-07-02 under 510(k) number K901880. The device is classified under product code MOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDILENS(TM) CORNEAL SHIELD?

MEDILENS(TM) CORNEAL SHIELD is a medical device that received FDA 510(k) clearance on 1990-07-02. The listed applicant is Chiron Ophthalmics. The 510(k) number is K901880.

When did MEDILENS(TM) CORNEAL SHIELD receive FDA 510(k) clearance?

MEDILENS(TM) CORNEAL SHIELD received FDA 510(k) clearance on 1990-07-02, under 510(k) number K901880.

Who is the listed applicant for MEDILENS(TM) CORNEAL SHIELD?

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

What is the FDA product code for MEDILENS(TM) CORNEAL SHIELD?

The FDA product code for MEDILENS(TM) CORNEAL SHIELD is MOE.

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 Chiron Ophthalmics 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.

K915861MEDILENS-CS CORNEAL SHIELDK914311CHIROFLEX II LENS MICROSERT(TM)K905825COLLAGEN SHIELD, VARIOUS MODELSK903575CHIROFLEX FORCEPSK903574CHIROFLEX LENS MICROSERTK894162OPTISOL

View all 10 devices →

Related Devices (Code: MOE)

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.

K944872BIO-COR COLLAGEN CORNEAL SHIELDBausch & Lomb Healthcare and Optics WorldwideK915861MEDILENS-CS CORNEAL SHIELDChiron OphthalmicsK914529SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDSOasis Medical, Inc.K913148COLLAGEN SHIELD FOR ACUTE CAREVitaphore Corp.K905825COLLAGEN SHIELD, VARIOUS MODELSChiron OphthalmicsK902558COLLAGEN SHIELD FOR ACUTE CAREVitaphore Corp.

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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