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 |