Device Classification Name |
Apparatus, Electrosurgical
|
510(k) Number |
K871435 |
Device Name |
BARD EMS SYSTEM 6000 E.S.U. |
Applicant |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Applicant Contact |
CATHERINE V BEATH |
Correspondent |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Correspondent Contact |
CATHERINE V BEATH |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/13/1987 |
Decision Date | 05/11/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|