The following data is part of a premarket notification filed by Ncontact Surgical, Inc. with the FDA for Ncontact Coagulation System Kit, Model Csk.
Device ID | K063012 |
510k Number | K063012 |
Device Name: | NCONTACT COAGULATION SYSTEM KIT, MODEL CSK |
Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
Applicant | NCONTACT SURGICAL, INC. 2880 SLATER ROAD SUITE 103 Morrisville, NC 27560 |
Contact | Jane Ricupero |
Correspondent | Jane Ricupero NCONTACT SURGICAL, INC. 2880 SLATER ROAD SUITE 103 Morrisville, NC 27560 |
Product Code | OCL |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-02 |
Decision Date | 2006-12-01 |
Summary: | summary |