MICROSIL

Hearing Aid, Air Conduction

MICROSONIC, INC.

The following data is part of a premarket notification filed by Microsonic, Inc. with the FDA for Microsil.

Pre-market Notification Details

• Device ID: K945255
• 510k Number: K945255
• Device Name: MICROSIL
• Classification: Hearing Aid, Air Conduction
• Applicant: MICROSONIC, INC. 1421 MERCHANT ST. P.O. BOX 184 Ambridge, PA 15003
• Contact: Miklos Major
• Correspondent: Miklos Major; MICROSONIC, INC. 1421 MERCHANT ST. P.O. BOX 184 Ambridge, PA 15003
• Product Code: ESD
• CFR Regulation Number: 874.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-28
• Decision Date: 1994-11-29