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FDA 510(k)

BIO-COR COLLAGEN CORNEAL SHIELD

K-Number: K944872 · 1995-07-26

ApplicantBausch & Lomb Healthcare and Optics Worldwide
Decision Date1995-07-26
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIO-COR COLLAGEN CORNEAL SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb Healthcare and Optics Worldwide. It received FDA 510(k) clearance on 1995-07-26 under 510(k) number K944872. 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 BIO-COR COLLAGEN CORNEAL SHIELD?

BIO-COR COLLAGEN CORNEAL SHIELD is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Bausch & Lomb Healthcare and Optics Worldwide. The 510(k) number is K944872.

When did BIO-COR COLLAGEN CORNEAL SHIELD receive FDA 510(k) clearance?

BIO-COR COLLAGEN CORNEAL SHIELD received FDA 510(k) clearance on 1995-07-26, under 510(k) number K944872.

Who is the listed applicant for BIO-COR COLLAGEN CORNEAL SHIELD?

The FDA 510(k) record lists Bausch & Lomb Healthcare and Optics Worldwide as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-COR COLLAGEN CORNEAL SHIELD?

The FDA product code for BIO-COR COLLAGEN CORNEAL SHIELD is MOE.

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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.

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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.

K915861MEDILENS-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.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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