Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K002916 |
Device Name |
SURGI-VISION PROSTATE COIL |
Applicant |
SURGI-VISION, INC. |
9250 RUMSEY RD., SUITE 100 |
COLUMBIA,
MD
21045
|
|
Applicant Contact |
NANCY E TAYLOR |
Correspondent |
SURGI-VISION, INC. |
9250 RUMSEY RD., SUITE 100 |
COLUMBIA,
MD
21045
|
|
Correspondent Contact |
NANCY E TAYLOR |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 09/19/2000 |
Decision Date | 11/28/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|