Device Classification Name |
electrode, electrosurgical, active, urological
|
510(k) Number |
K050488 |
Device Name |
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES |
Applicant |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
ASHVIN DESAI |
Correspondent |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
ASHVIN DESAI |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 02/25/2005 |
Decision Date | 04/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|