Device Classification Name |
Table, Radiographic, Stationary Top
|
510(k) Number |
K973842 |
Device Name |
CARBON FIBER CONFORMAL COUCH TOP |
Applicant |
MEDTEC, INC. |
1401 8TH ST. S.E. |
P.O. BOX 602 |
ORANGE CITY,
IA
51041
|
|
Applicant Contact |
DONALD F RIIBE |
Correspondent |
MEDTEC, INC. |
1401 8TH ST. S.E. |
P.O. BOX 602 |
ORANGE CITY,
IA
51041
|
|
Correspondent Contact |
DONALD F RIIBE |
Regulation Number | 892.1980
|
Classification Product Code |
|
Date Received | 10/08/1997 |
Decision Date | 12/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|