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510(k) Data Aggregation

K Number

Device Name

IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT

Manufacturer

BELTONE ELECTRONICS CORP.

Date Cleared

1996-12-05

(64 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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