Device Classification Name |
pump, infusion, elastomeric
|
510(k) Number |
K081905 |
Device Name |
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP |
Applicant |
Westmed, Inc. |
3957 BLUE PINE CIRCLE |
HIGHLANDS RANCH,
CO
80126 -8077
|
|
Applicant Contact |
CHARLES M HART |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/03/2008 |
Decision Date | 07/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|