510(k) K935085
K935085 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code LWM (Device, Electrical Dental Anesthesia), a Class U device. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1994
- Date Received
- October 22, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Electrical Dental Anesthesia
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type