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510(k) Data Aggregation

K Number

Device Name

PRIMOFOCUS COMPACT

Manufacturer

Date Cleared

1996-11-27

(68 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

OTICON CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

To amplify and deliver sound to the ear.

Device Description

BTE Hearing Aid

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