The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Egs Serosafuse Implantable Fasteners, Associated Delivery Devices And Accessories.
| Device ID | K071651 |
| 510k Number | K071651 |
| Device Name: | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond, WA 98052 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond, WA 98052 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-18 |
| Decision Date | 2007-09-14 |
| Summary: | summary |