Device Classification Name |
System, Perfusion, Kidney
|
510(k) Number |
K972066 |
Device Name |
BELZER-MPS |
Applicant |
TRANS-MED CORP. |
230 EVANS AVE. |
ELK RIVER,
MN
55330
|
|
Applicant Contact |
SAMUEL C MCGHEE |
Correspondent |
TRANS-MED CORP. |
230 EVANS AVE. |
ELK RIVER,
MN
55330
|
|
Correspondent Contact |
SAMUEL C MCGHEE |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 06/03/1997 |
Decision Date | 11/26/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|