Device Classification Name |
catheter, electrode recording, or probe, electrode recording
|
510(k) Number |
K982415 |
Device Name |
CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 |
Applicant |
CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. |
BALDWIN PARK,
CA
91706
|
|
Applicant Contact |
MARY ADAMS |
Correspondent |
CORDIS WEBSTER, INC. |
4750 LITTLEJOHN ST. |
BALDWIN PARK,
CA
91706
|
|
Correspondent Contact |
MARY ADAMS |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 07/13/1998 |
Decision Date | 08/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|