OTOLOGICAL VENTILATION TUBES-VARIOUS

Tube, Tympanostomy

MICROMEDICS, INC.

The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Otological Ventilation Tubes-various.

Pre-market Notification Details

• Device ID: K830228
• 510k Number: K830228
• Device Name: OTOLOGICAL VENTILATION TUBES-VARIOUS
• Classification: Tube, Tympanostomy
• Applicant: MICROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: ETD
• CFR Regulation Number: 874.3880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-01-24
• Decision Date: 1983-03-07

NIH GUDID Devices

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