OTO-CEM

Cement, Ear, Nose And Throat

OTOTECH, INC.

The following data is part of a premarket notification filed by Ototech, Inc. with the FDA for Oto-cem.

Pre-market Notification Details

• Device ID: K011338
• 510k Number: K011338
• Device Name: OTO-CEM
• Classification: Cement, Ear, Nose And Throat
• Applicant: OTOTECH, INC. 1625 K STREET, NW SUITE 1000 Washington, DC 20006
• Contact: Michael G Farrow
• Correspondent: Michael G Farrow; OTOTECH, INC. 1625 K STREET, NW SUITE 1000 Washington, DC 20006
• Product Code: NEA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-05-02
• Decision Date: 2001-09-13