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FDA 510(k)

COI 24 HR COLLAGEN SHIELD

K-Number: K885016 · 1989-02-01

ApplicantChiron Ophthalmics
Decision Date1989-02-01
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COI 24 HR COLLAGEN 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 1989-02-01 under 510(k) number K885016. 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 COI 24 HR COLLAGEN SHIELD?

COI 24 HR COLLAGEN SHIELD is a medical device that received FDA 510(k) clearance on 1989-02-01. The listed applicant is Chiron Ophthalmics. The 510(k) number is K885016.

When did COI 24 HR COLLAGEN SHIELD receive FDA 510(k) clearance?

COI 24 HR COLLAGEN SHIELD received FDA 510(k) clearance on 1989-02-01, under 510(k) number K885016.

Who is the listed applicant for COI 24 HR COLLAGEN 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 COI 24 HR COLLAGEN SHIELD?

The FDA product code for COI 24 HR COLLAGEN SHIELD 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)K905825COLLAGEN SHIELD, VARIOUS MODELSK903575CHIROFLEX FORCEPSK903574CHIROFLEX LENS MICROSERTK901880MEDILENS(TM) CORNEAL SHIELD

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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