The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Equestra Fluid Delivery System.
| Device ID | K043568 |
| 510k Number | K043568 |
| Device Name: | EQUESTRA FLUID DELIVERY SYSTEM |
| Classification | Arthroscope |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-01-25 |
| Summary: | summary |