The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Dental Electronic Anesthesia (dea) System 8670.
Device ID | K935304 |
510k Number | K935304 |
Device Name: | 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 |
Classification | Device, Electrical Dental Anesthesia |
Applicant | 3M COMPANY LIME ST., P.O. BOX 9 Marblehead, MA 01945 |
Contact | Paul A Burgio |
Correspondent | Paul A Burgio 3M COMPANY LIME ST., P.O. BOX 9 Marblehead, MA 01945 |
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 | 1993-11-02 |
Decision Date | 1994-03-16 |