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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

SINUSCOPE AND BACCESSORIES

Manufacturer

POLLUX ENDOSCOPY, INC.

Date Cleared

2000-11-21

(120 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K063078,K100577

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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AI/ML Overview

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