The following data is part of a premarket notification filed by Accellent Inc. with the FDA for Guidewire, Model G-v220-3527s And Others.
| Device ID | K072354 |
| 510k Number | K072354 |
| Device Name: | GUIDEWIRE, MODEL G-V220-3527S AND OTHERS |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | ACCELLENT INC. 100 FORDHAM ROAD Wilmington, MA 01887 |
| Contact | Karl Steineck |
| Correspondent | Karl Steineck ACCELLENT INC. 100 FORDHAM ROAD Wilmington, MA 01887 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-22 |
| Decision Date | 2007-12-07 |
| Summary: | summary |