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510(k) Data Aggregation

K Number

Device Name

GAYHEART CORNEAL EXCISION DEVICE

Manufacturer

STEPHENS INSTRUMENTS

Date Cleared

2002-11-01

(66 days)

Product Code

HRH

Regulation Number

886.4350

Why did this record match?

Product Code :

HRH

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Trephine made for single use and for the extraction of the cornea.

Device Description

A single use ophthalmic device designed to extract the cornea.

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