The following data is part of a premarket notification filed by Midas Rex Pneumatic Tools, Inc. with the FDA for Gs & Gs20 Surgical Tool System.
| Device ID | K952463 |
| 510k Number | K952463 |
| Device Name: | GS & GS20 SURGICAL TOOL SYSTEM |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
| Contact | Forest Barber, Jr. |
| Correspondent | Forest Barber, Jr. MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-26 |
| Decision Date | 1995-07-17 |