The following data is part of a premarket notification filed by Special Devices, Inc. with the FDA for Eutrochar.
| Device ID | K050957 |
| 510k Number | K050957 |
| Device Name: | EUTROCHAR |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | SPECIAL DEVICES, INC. 12493 OLD ROUGH AND READY HWY. Grass Valley, CA 95945 |
| Contact | Joseph J Spranza Iii |
| Correspondent | Joseph J Spranza Iii SPECIAL DEVICES, INC. 12493 OLD ROUGH AND READY HWY. Grass Valley, CA 95945 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-15 |
| Decision Date | 2005-05-18 |
| Summary: | summary |