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510(k) Data Aggregation

K Number

Device Name

PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI

Manufacturer

Date Cleared

2001-12-13

(65 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

SURGIN INC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Surgin's Prizm Blades are designed as replacement blades for the Nidek Model MK2000 keratome.

Device Description

Not Found

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