The following data is part of a premarket notification filed by Conmed Endoscopic Technologies, Inc. with the FDA for Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998.
| Device ID | K091355 |
| 510k Number | K091355 |
| Device Name: | DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 |
| Classification | Snare, Flexible |
| Applicant | CONMED ENDOSCOPIC TECHNOLOGIES, INC. ONE EXECUTIVE DRIVE SUITE 101 Chelmsford, MA 01824 |
| Contact | Karen Provencher |
| Correspondent | Karen Provencher CONMED ENDOSCOPIC TECHNOLOGIES, INC. ONE EXECUTIVE DRIVE SUITE 101 Chelmsford, MA 01824 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-07-22 |
| Summary: | summary |