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FDA 510(k)

COLLAGEN SHIELD, VARIOUS MODELS

K-Number: K905825 · 1991-06-10

ApplicantChiron Ophthalmics
Decision Date1991-06-10
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COLLAGEN SHIELD, VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Ophthalmics. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K905825. 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 COLLAGEN SHIELD, VARIOUS MODELS?

COLLAGEN SHIELD, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Chiron Ophthalmics. The 510(k) number is K905825.

When did COLLAGEN SHIELD, VARIOUS MODELS receive FDA 510(k) clearance?

COLLAGEN SHIELD, VARIOUS MODELS received FDA 510(k) clearance on 1991-06-10, under 510(k) number K905825.

Who is the listed applicant for COLLAGEN SHIELD, VARIOUS MODELS?

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 COLLAGEN SHIELD, VARIOUS MODELS?

The FDA product code for COLLAGEN SHIELD, VARIOUS MODELS is MOE.

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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)K903575CHIROFLEX FORCEPSK903574CHIROFLEX LENS MICROSERTK901880MEDILENS(TM) CORNEAL SHIELDK894162OPTISOL

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.K902558COLLAGEN SHIELD FOR ACUTE CAREVitaphore Corp.K901880MEDILENS(TM) CORNEAL SHIELDChiron Ophthalmics

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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