Device Classification Name |
manometer, spinal-fluid
|
510(k) Number |
K970287 |
Device Name |
LUMBAR PUNCTURE KIT |
Applicant |
B. BRAUN MEDICAL, INC. |
824 12TH AVE. |
BETHLEHEM,
PA
18018
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN MEDICAL, INC. |
824 12TH AVE. |
BETHLEHEM,
PA
18018
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 880.2500
|
Classification Product Code |
|
Date Received | 01/24/1997 |
Decision Date | 04/07/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|