The following data is part of a premarket notification filed by Midas Rex Pneumatic Tools, Inc. with the FDA for Midas Rex Drill Attachments & Twist Drills.
| Device ID | K954076 |
| 510k Number | K954076 |
| Device Name: | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | MIDAS REX PNEUMATIC TOOLS, INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer MIDAS REX PNEUMATIC TOOLS, INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-30 |
| Decision Date | 1995-10-18 |