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FDA 510(k)

LANDERS-FOULKS TEMP. KERATOPROSTHESIS

K-Number: K842856 · 1984-12-18

ApplicantOcular Instruments, Inc.
Decision Date1984-12-18
Product CodeMLP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LANDERS-FOULKS TEMP. KERATOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Instruments, Inc.. It received FDA 510(k) clearance on 1984-12-18 under 510(k) number K842856. The device is classified under product code MLP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANDERS-FOULKS TEMP. KERATOPROSTHESIS?

LANDERS-FOULKS TEMP. KERATOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1984-12-18. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K842856.

When did LANDERS-FOULKS TEMP. KERATOPROSTHESIS receive FDA 510(k) clearance?

LANDERS-FOULKS TEMP. KERATOPROSTHESIS received FDA 510(k) clearance on 1984-12-18, under 510(k) number K842856.

Who is the listed applicant for LANDERS-FOULKS TEMP. KERATOPROSTHESIS?

The FDA 510(k) record lists Ocular Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LANDERS-FOULKS TEMP. KERATOPROSTHESIS?

The FDA product code for LANDERS-FOULKS TEMP. KERATOPROSTHESIS is MLP.

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Other records listing Ocular Instruments, Inc. as applicant

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Related Devices (Code: MLP)

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.

K261312Temporary Keratoprosthesis (QuickSet TKP™)Eyekon Medical, Inc.K910828LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESISOcular Instruments, Inc.K902491ECKHARDT TEMPORARY KERATOPROSTHESISDutch Ophthalmic USA, Inc.K895013COBO TEMPORARY KERATOPROSTHESISOcular Instruments, Inc.

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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