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FDA 510(k)

LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL

K-Number: K884363 · 1988-11-29

ApplicantBausch & Lomb Pharmaceutical, Inc.
Decision Date1988-11-29
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb Pharmaceutical, Inc.. It received FDA 510(k) clearance on 1988-11-29 under 510(k) number K884363. 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 LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL?

LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL is a medical device that received FDA 510(k) clearance on 1988-11-29. The listed applicant is Bausch & Lomb Pharmaceutical, Inc.. The 510(k) number is K884363.

When did LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL receive FDA 510(k) clearance?

LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL received FDA 510(k) clearance on 1988-11-29, under 510(k) number K884363.

Who is the listed applicant for LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL?

The FDA 510(k) record lists Bausch & Lomb Pharmaceutical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL?

The FDA product code for LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL 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.

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Other records listing Bausch & Lomb Pharmaceutical, 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.

K884962ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEAK884960ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEALK884961ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEALK884362LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLDK884364LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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