Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K023291 |
Device Name |
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X |
Applicant |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
ANDREA L RUTH |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
ANDREA L RUTH |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/02/2002 |
Decision Date | 10/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|