510(k) K900388 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
| Applicant | Midas Rex Pneumatic Tools, Inc., Fort Worth TX, US |
| Decision | Substantially Equivalent, May 7, 1990 |
| Received | Jan 29, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900388
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2005 | Power Surgical Solutions Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use O Terminated |
GET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.