The following data is part of a premarket notification filed by Techdevice Corporation with the FDA for Techdevice Guidewire.
| Device ID | K053028 |
| 510k Number | K053028 |
| Device Name: | TECHDEVICE GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Contact | Leigh Hayward |
| Correspondent | Leigh Hayward TECHDEVICE CORPORATION 650 PLEASANT ST. Watertown, MA 02472 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-27 |
| Decision Date | 2006-01-31 |
| Summary: | summary |