The following data is part of a premarket notification filed by Advanced Surgical Concepts with the FDA for R-port Laparoscopic Access Device.
| Device ID | K070158 |
| 510k Number | K070158 |
| Device Name: | R-PORT LAPAROSCOPIC ACCESS DEVICE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ADVANCED SURGICAL CONCEPTS 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Tanya Kavanagh |
| Correspondent | Tanya Kavanagh ADVANCED SURGICAL CONCEPTS 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-17 |
| Decision Date | 2007-08-23 |
| Summary: | summary |