Device Classification Name |
probe, uptake, nuclear
|
510(k) Number |
K922117 |
Device Name |
C-TRAK BIOPSY SYSTEM |
Applicant |
CARE WISE MEDICAL PRODUCTS CORP. |
P.O. BOX 1655 |
MORGAN HILL,
CA
95038 -1655
|
|
Applicant Contact |
WISE, JR. |
Correspondent |
CARE WISE MEDICAL PRODUCTS CORP. |
P.O. BOX 1655 |
MORGAN HILL,
CA
95038 -1655
|
|
Correspondent Contact |
WISE, JR. |
Regulation Number | 892.1320
|
Classification Product Code |
|
Date Received | 05/05/1992 |
Decision Date | 10/14/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|