Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K964968 |
Device Name |
MR EXTENSION SET (001) |
Applicant |
UNIVERSITY OF MICHIGAN |
1500 EAST, MEDICAL CENTER DR. |
ANN ARBOR,,
MI
48109 -0340
|
|
Applicant Contact |
MARTIN R PRINCE, MD, PH.D. |
Correspondent |
UNIVERSITY OF MICHIGAN |
1500 EAST, MEDICAL CENTER DR. |
ANN ARBOR,,
MI
48109 -0340
|
|
Correspondent Contact |
MARTIN R PRINCE, MD, PH.D. |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/12/1996 |
Decision Date | 02/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|