The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Maxi-driver Ii Electric System.
Device ID | K951118 |
510k Number | K951118 |
Device Name: | 3M MAXI-DRIVER II ELECTRIC SYSTEM |
Classification | Motor, Surgical Instrument, Ac-powered |
Applicant | 3M COMPANY 4320 VANOWEN ST. Burbank, CA 91505 |
Contact | Willard Larson |
Correspondent | Willard Larson 3M COMPANY 4320 VANOWEN ST. Burbank, CA 91505 |
Product Code | GEY |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-10 |
Decision Date | 1995-07-06 |