OTO-CEM— 510(k) K011338

Substantially Equivalent

Ototech, Inc.

FDA 510(k) clearance K011338 for OTO-CEM, Substantially Equivalent on 2001-09-13. Applicant: Ototech, Inc..

Clearance details

Applicant: Ototech, Inc.
Product code: Code NEA
Advisory panel: Dental
Date received: 2001-05-02
Decision date: 2001-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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