Device Classification Name |
coil, magnetic resonance, specialty
|
510(k) Number |
K013810 |
Device Name |
CARDIOVASCULAR ARRAY |
Applicant |
W.L. GORE & ASSOCIATES,INC |
1901 BARKSDALE RD. |
NEWARK,
DE
19714
|
|
Applicant Contact |
TRACEY D WOLF |
Correspondent |
TUV PRODUCT SERVICE, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/15/2001 |
Decision Date | 11/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|