The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Mini-driver Electric System.
| Device ID | K955098 |
| 510k Number | K955098 |
| Device Name: | 3M MINI-DRIVER ELECTRIC SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Contact | Betty L Faladeaux |
| Correspondent | Betty L Faladeaux 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-07 |
| Decision Date | 1996-01-22 |