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510(k) Data Aggregation

K Number

Device Name

Leo Minor

Manufacturer

SUNNEX, INC.

Date Cleared

2014-10-29

(13 days)

Product Code

FSY

Regulation Number

878.4580

Why did this record match?

Applicant Name (Manufacturer) :

SUNNEX, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Leo Minor is intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.

Device Description

Not Found

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