Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K973366 |
Device Name |
COBRA HAND PIECE |
Applicant |
VIDAMED, INC. |
46107 LANDING PKWY. |
FREMONT,
CA
94538
|
|
Applicant Contact |
ROBIN BUSH |
Correspondent |
VIDAMED, INC. |
46107 LANDING PKWY. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
ROBIN BUSH |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 09/08/1997 |
Decision Date | 11/26/1997 |
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
|
|
|