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510(k) Data Aggregation

K Number

Device Name

OTO-CEM

Manufacturer

OTOTECH, INC.

Date Cleared

2001-09-13

(134 days)

Product Code

NEA

Regulation Number

872.3275

Why did this record match?

Applicant Name (Manufacturer) :

OTOTECH, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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