510(k) K850344
K850344 is an FDA 510(k) premarket notification submitted by Midwest for the device "AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG". The FDA issued a decision of Substantially Equivalent on March 25, 1985. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Midwest has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1985
- Date Received
- January 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type