The following data is part of a premarket notification filed by Microsonic, Inc. with the FDA for Mega-sil A-b.
| Device ID | K950912 |
| 510k Number | K950912 |
| Device Name: | MEGA-SIL A-B |
| 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 | 1995-02-27 |
| Decision Date | 1995-03-21 |