Device Classification Name |
Catheter, Electrode Recording, Or Probe, Electrode Recording
|
510(k) Number |
K980961 |
Device Name |
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. |
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 | 03/16/1998 |
Decision Date | 05/28/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|