Device Classification Name |
surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
|
510(k) Number |
K090202 |
Device Name |
NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 |
Applicant |
NCONTACT SURGICAL, INC. |
1001 AVIATION PARKWAY |
SUITE 400 |
MORRISVILLE,
NC
27560
|
|
Applicant Contact |
JANE RICUPERO |
Correspondent |
NCONTACT SURGICAL, INC. |
1001 AVIATION PARKWAY |
SUITE 400 |
MORRISVILLE,
NC
27560
|
|
Correspondent Contact |
JANE RICUPERO |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/27/2009 |
Decision Date | 02/17/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|