Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K000508 |
Device Name |
THERMOFLEX SYSTEM |
Applicant |
ARGOMED, INC. |
3800 GATEWAY CENTER BLVD. |
MORRISVILLE,
NC
27560
|
|
Applicant Contact |
RICHARD B KLEIN |
Correspondent |
ARGOMED, INC. |
3800 GATEWAY CENTER BLVD. |
MORRISVILLE,
NC
27560
|
|
Correspondent Contact |
RICHARD B KLEIN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 02/15/2000 |
Decision Date | 04/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|