Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K991847 |
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 |
|
Subsequent Product Codes |
|
Date Received | 05/28/1999 |
Decision Date | 08/26/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|