BOSTON KERATOPROSTHESIS OR BOSTON KPRO— 510(k) K121203

Name: FDA 510(k) clearance K121203
Creator: U.S. Food and Drug Administration
Published: 2013-05-10

Substantially Equivalent

Massachusetts Eye & Ear Infirmary

FDA 510(k) clearance K121203 for BOSTON KERATOPROSTHESIS OR BOSTON KPRO, Substantially Equivalent on 2013-05-10. Applicant: Massachusetts Eye & Ear Infirmary. Device class: 2.

Clearance details

Applicant: Massachusetts Eye & Ear Infirmary
Product code: Code HQM
Device class: Class 2
Regulation: 21 CFR 886.3400
Advisory panel: Ophthalmic
Date received: 2012-04-20
Decision date: 2013-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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