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510(k) Data Aggregation

K Number

Device Name

PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

Manufacturer

ATOS MEDICAL AB

Date Cleared

2010-10-14

(416 days)

Product Code

Regulation Number

Type

Panel

Ear, Nose, and Throat (EN)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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