The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Endolink True Movement System.
| Device ID | K043541 |
| 510k Number | K043541 |
| Device Name: | ENDOLINK TRUE MOVEMENT SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NOVARE SURGICAL SYSTEMS, INC. 3924 CASCADE BEACH ROAD Lutsen, MN 55612 |
| Contact | Gregory Mathison |
| Correspondent | Gregory Mathison NOVARE SURGICAL SYSTEMS, INC. 3924 CASCADE BEACH ROAD Lutsen, MN 55612 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-22 |
| Decision Date | 2005-03-10 |
| Summary: | summary |