The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Dental Electronic Anesthesia System.
Device ID | K920119 |
510k Number | K920119 |
Device Name: | 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM |
Classification | Device, Electrical Dental Anesthesia |
Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Contact | Paul A Burgio |
Correspondent | Paul A Burgio 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Product Code | LWM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-10 |
Decision Date | 1992-05-22 |