The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Equestra Fluid Delivery System.
| Device ID | K040483 |
| 510k Number | K040483 |
| Device Name: | EQUESTRA FLUID DELIVERY SYSTEM |
| Classification | Arthroscope |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-25 |
| Decision Date | 2004-07-23 |
| Summary: | summary |