Device Classification Name |
Monitor, Spinal-Fluid Pressure, Electrically Powered
|
510(k) Number |
K926066 |
Device Name |
BION MUMPS-G ANTIBODY TEST SYSTEM |
Applicant |
BION ENT., LTD. |
674 BUSSE HWY. |
PARK RIDGE,
IL
60068
|
|
Applicant Contact |
EDWARD NOWAKOWSKI |
Correspondent |
BION ENT., LTD. |
674 BUSSE HWY. |
PARK RIDGE,
IL
60068
|
|
Correspondent Contact |
EDWARD NOWAKOWSKI |
Regulation Number | 880.2460
|
Classification Product Code |
|
Date Received | 12/01/1992 |
Decision Date | 06/15/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|