The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Medtronic Graft Delivery Syringe.
| Device ID | K062986 |
| 510k Number | K062986 |
| Device Name: | MEDTRONIC GRAFT DELIVERY SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Edward S Chin |
| Correspondent | Edward S Chin MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2006-12-08 |
| Summary: | summary |