Device Classification Name |
pump, infusion, elastomeric
|
510(k) Number |
K062457 |
Device Name |
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES |
Applicant |
BAXTER HEALTHCARE CORPORATION |
1620 WAUKEGAN RD. |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
NANETTE HEDDEN |
Correspondent |
BAXTER HEALTHCARE CORPORATION |
1620 WAUKEGAN RD. |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
NANETTE HEDDEN |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/23/2006 |
Decision Date | 09/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|