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FDA 510(k)

LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS

K-Number: K910828 · 1991-08-21

ApplicantOcular Instruments, Inc.
Decision Date1991-08-21
Product CodeMLP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LANDERS WIDE FIELD TEMPORARY 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 1991-08-21 under 510(k) number K910828. 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 WIDE FIELD TEMPORARY KERATOPROSTHESIS?

LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1991-08-21. The listed applicant is Ocular Instruments, Inc.. The 510(k) number is K910828.

When did LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS receive FDA 510(k) clearance?

LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS received FDA 510(k) clearance on 1991-08-21, under 510(k) number K910828.

Who is the listed applicant for LANDERS WIDE FIELD TEMPORARY 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 WIDE FIELD TEMPORARY KERATOPROSTHESIS?

The FDA product code for LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS is MLP.

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Other records listing Ocular Instruments, 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.

K014170STAURENGHI WIDE FIELD SCANNING LASER LENSK012096DISPOSABLE VITRECTOMY LENSK933976MANDELKORN SUTURE LYSIS LENSK933264RITCH NYLON SUTURE LASER LENSK94142050 DEGREE HRI PRISM LENSK935302OSHER SURGICAL GONIO/POSTERIOR POLE LENS

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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.K902491ECKHARDT TEMPORARY KERATOPROSTHESISDutch Ophthalmic USA, 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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