Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K021266 |
Device Name |
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 |
Applicant |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
KEN CHARAK |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
KEN CHARAK |
Regulation Number | 876.4300 |
Classification Product Code |
|
Date Received | 04/22/2002 |
Decision Date | 09/27/2002 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|