The following data is part of a premarket notification filed by Midas Rex Pneumatic Tools, Inc. with the FDA for Midas Rex Iii Motor And Attachments (midas Iii).
| Device ID | K970965 |
| 510k Number | K970965 |
| Device Name: | MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
| Contact | Michael Fowler |
| Correspondent | Michael Fowler MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-04-09 |
| Summary: | summary |