The following data is part of a premarket notification filed by Midwest with the FDA for Am-40 Power Optic Air Motor Power Optic Contra Ang.
| Device ID | K850344 |
| 510k Number | K850344 |
| Device Name: | AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | MIDWEST 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | James E Kettner |
| Correspondent | James E Kettner MIDWEST 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-03-25 |