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FDA 510(k)

ECKHARDT TEMPORARY KERATOPROSTHESIS

K-Number: K902491 · 1990-06-26

ApplicantDutch Ophthalmic USA, Inc.
Decision Date1990-06-26
Product CodeMLP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ECKHARDT TEMPORARY KERATOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic USA, Inc.. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K902491. 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 ECKHARDT TEMPORARY KERATOPROSTHESIS?

ECKHARDT TEMPORARY KERATOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Dutch Ophthalmic USA, Inc.. The 510(k) number is K902491.

When did ECKHARDT TEMPORARY KERATOPROSTHESIS receive FDA 510(k) clearance?

ECKHARDT TEMPORARY KERATOPROSTHESIS received FDA 510(k) clearance on 1990-06-26, under 510(k) number K902491.

Who is the listed applicant for ECKHARDT TEMPORARY KERATOPROSTHESIS?

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

What is the FDA product code for ECKHARDT TEMPORARY KERATOPROSTHESIS?

The FDA product code for ECKHARDT TEMPORARY KERATOPROSTHESIS is MLP.

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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.K895013COBO TEMPORARY KERATOPROSTHESISOcular Instruments, Inc.K842856LANDERS-FOULKS TEMP. 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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