Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K011787 |
Device Name |
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE |
Applicant |
VIDAMED, INC. |
46107 LANDING PKWY. |
FREMONT,
CA
94538
|
|
Applicant Contact |
YI CHEN |
Correspondent |
VIDAMED, INC. |
46107 LANDING PKWY. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
YI CHEN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/08/2001 |
Decision Date | 07/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|