The following data is part of a premarket notification filed by Ncontact Surgical, Inc. with the FDA for Ncontact Visitrax Guided Coagulation System Kit, Models Csk-212 And Csk-515.
Device ID | K071819 |
510k Number | K071819 |
Device Name: | NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 |
Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
Applicant | NCONTACT SURGICAL, INC. 1001 AVIATION PARKWAY SUITE 400 Morrisville, NC 27560 |
Contact | Jane Ricupero |
Correspondent | Jane Ricupero NCONTACT SURGICAL, INC. 1001 AVIATION PARKWAY SUITE 400 Morrisville, NC 27560 |
Product Code | OCL |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-03 |
Decision Date | 2007-07-26 |
Summary: | summary |