K954076 is an FDA 510(k) clearance for the MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS. This device is classified as a Motor, Surgical Instrument, Pneumatic Powered (Class I - General Controls, product code GET).
Submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on October 18, 1995, 49 days after receiving the submission on August 30, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K954076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1995 |
| Decision Date | October 18, 1995 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GET — Motor, Surgical Instrument, Pneumatic Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |