The following data is part of a premarket notification filed by Ndo Surgical, Inc. with the FDA for Modification To Endoscopic Plication System.
| Device ID | K032820 |
| 510k Number | K032820 |
| Device Name: | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield, MA 02048 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield, MA 02048 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-10 |
| Decision Date | 2003-10-23 |
| Summary: | summary |