The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Symphony Graft Delivery System (gds).
| Device ID | K012738 |
| 510k Number | K012738 |
| Device Name: | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Karen F Jurczak |
| Correspondent | Karen F Jurczak DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2001-11-14 |
| Summary: | summary |