Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K961841 |
Device Name |
BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
EVANS YI-WEN WUU |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
EVANS YI-WEN WUU |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 05/13/1996 |
Decision Date | 10/09/1996 |
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
|
|
|