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FDA 510(k)

BOSTON KERATOPROSTHESIS OR BOSTON KPRO

K-Number: K121203 · 2013-05-10

ApplicantMassachusetts Eye & Ear Infirmary
Decision Date2013-05-10
Product CodeHQM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOSTON KERATOPROSTHESIS OR BOSTON KPRO is the device name listed in this FDA 510(k) record. The listed applicant is Massachusetts Eye & Ear Infirmary. It received FDA 510(k) clearance on 2013-05-10 under 510(k) number K121203. The device is classified under product code HQM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSTON KERATOPROSTHESIS OR BOSTON KPRO?

BOSTON KERATOPROSTHESIS OR BOSTON KPRO is a medical device that received FDA 510(k) clearance on 2013-05-10. The listed applicant is Massachusetts Eye & Ear Infirmary. The 510(k) number is K121203.

When did BOSTON KERATOPROSTHESIS OR BOSTON KPRO receive FDA 510(k) clearance?

BOSTON KERATOPROSTHESIS OR BOSTON KPRO received FDA 510(k) clearance on 2013-05-10, under 510(k) number K121203.

Who is the listed applicant for BOSTON KERATOPROSTHESIS OR BOSTON KPRO?

The FDA 510(k) record lists Massachusetts Eye & Ear Infirmary as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON KERATOPROSTHESIS OR BOSTON KPRO?

The FDA product code for BOSTON KERATOPROSTHESIS OR BOSTON KPRO is HQM.

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Related Devices (Code: HQM)

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.

K182986Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A BostonK013756ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)Argus Biomedical Pty, Ltd.K915062DOHLMAN DOANE KERATOPROTHESISMackeen Consultants, Ltd.

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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