K953433 is an FDA 510(k) clearance for the MIDAS REX TELESCOPING SYSTEM, 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 September 15, 1995, 56 days after receiving the submission on July 21, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K953433 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 21, 1995 |
| Decision Date | September 15, 1995 |
| Days to Decision | 56 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 |