Device Classification Name |
Table, Radiographic, Tilting
|
510(k) Number |
K943581 |
Device Name |
HYDRADJUST IV UROLOGICAL TABLE |
Applicant |
MALLINCKRODT GROUP, INC. |
2111 EAST GALBRAITH RD. |
P.O. BOX 156305 |
CINCINNATI,
OH
45215 -6305
|
|
Applicant Contact |
M.L. FRIEDMAN |
Correspondent |
MALLINCKRODT GROUP, INC. |
2111 EAST GALBRAITH RD. |
P.O. BOX 156305 |
CINCINNATI,
OH
45215 -6305
|
|
Correspondent Contact |
M.L. FRIEDMAN |
Regulation Number | 892.1980
|
Classification Product Code |
|
Date Received | 07/22/1994 |
Decision Date | 01/04/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|