The following data is part of a premarket notification filed by Ndo Surgical, Inc. with the FDA for Endoscopic Plication System; Eps; Plicator.
| Device ID | K071553 |
| 510k Number | K071553 |
| Device Name: | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield, MA 02048 |
| Contact | John J Vozella |
| Correspondent | John J Vozella NDO SURGICAL, INC. 125 HIGH ST., SUITE 7 Mansfield, MA 02048 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-06 |
| Decision Date | 2007-09-18 |
| Summary: | summary |