The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Model 8200p Multipro Bte.
| Device ID | K953543 |
| 510k Number | K953543 |
| Device Name: | 3M MODEL 8200P MULTIPRO BTE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 260-6A-19 St. Paul, MN 55144 -1000 |
| Contact | Joyce K Eyerly |
| Correspondent | Joyce K Eyerly 3M COMPANY 3M CENTER, BLDG. 260-6A-19 St. Paul, MN 55144 -1000 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1995-08-23 |