The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Maxi-driver Ii Dbattery Powered System.
| Device ID | K932307 |
| 510k Number | K932307 |
| Device Name: | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Willard Larson |
| Correspondent | Willard Larson 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-11 |
| Decision Date | 1994-01-07 |