The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Model 8295.
Device ID | K954067 |
510k Number | K954067 |
Device Name: | 3M MODEL 8295 |
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 | 1995-08-30 |
Decision Date | 1995-09-28 |