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FDA 510(k)

ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL

K-Number: K884960 · 1989-02-13

ApplicantBausch & Lomb Pharmaceutical, Inc.
Decision Date1989-02-13
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ADDIT. INDICATION FOR FYODOROV COLLAGEN 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 1989-02-13 under 510(k) number K884960. 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 ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL?

ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Bausch & Lomb Pharmaceutical, Inc.. The 510(k) number is K884960.

When did ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL receive FDA 510(k) clearance?

ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL received FDA 510(k) clearance on 1989-02-13, under 510(k) number K884960.

Who is the listed applicant for ADDIT. INDICATION FOR FYODOROV COLLAGEN 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 ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL?

The FDA product code for ADDIT. INDICATION FOR FYODOROV COLLAGEN 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 CORNEAK884961ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEALK884363LABELING CHANGES TO BIO-COR II COLLANGEN 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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