Device Classification Name |
syringe, piston
|
510(k) Number |
K952918 |
Device Name |
PTFE SYRINGE FILTER |
Applicant |
B. BRAUN MEDICAL, INC. |
805 GRANDVIEW DR. |
SO. SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
MARK ALSBERGE |
Correspondent |
B. BRAUN MEDICAL, INC. |
805 GRANDVIEW DR. |
SO. SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
MARK ALSBERGE |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 06/26/1995 |
Decision Date | 09/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|