Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K082163 |
Device Name |
FLOWMEDICA BENEPHIT INFUSION SYSTEMS |
Applicant |
FLOWMEDICA, INC. |
46563 FREMONT BLVD. |
FREMONT,
CA
94538
|
|
Applicant Contact |
JEFF ELKINS |
Correspondent |
FLOWMEDICA, INC. |
46563 FREMONT BLVD. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
JEFF ELKINS |
Regulation Number | 870.1210
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/31/2008 |
Decision Date | 10/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|