Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K031923 |
Device Name |
ULTRASITE VALVE |
Applicant |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 06/23/2003 |
Decision Date | 08/11/2003 |
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
|
|
|