The following data is part of a premarket notification filed by Midas Rex Pneumatic Tools, Inc. with the FDA for Modified Sterilization Of Drills, Burrs, Trephines.
| Device ID | K900388 |
| 510k Number | K900388 |
| Device Name: | MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
| Contact | Barber, Jr |
| Correspondent | Barber, Jr MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1990-05-07 |