The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Traction Polypectomy Snare.
| Device ID | K140923 |
| 510k Number | K140923 |
| Device Name: | TRACTION POLYPECTOMY SNARE |
| Classification | Snare, Flexible |
| Applicant | OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, Baden-wuerttemberg, DE 72074 |
| Contact | Tanja Linzer |
| Correspondent | Tanja Linzer OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, Baden-wuerttemberg, DE 72074 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-10 |
| Decision Date | 2014-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 4260206310549 | K140923 | 000 |