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510(k) Data Aggregation

K Number

Device Name

INSULATION TESTER

Manufacturer

SPECTRUM SURGICAL SUPPLY CORP.

Date Cleared

2012-03-27

(46 days)

Product Code

GEI

Regulation Number

878.4400

Why did this record match?

Applicant Name (Manufacturer) :

SPECTRUM SURGICAL SUPPLY CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Spectrum Insulation Tester checks for insulation integrity on laparoscopic instruments

Device Description

Insulation Tester

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