Device Classification Name |
Pump, Infusion, Elastomeric
|
510(k) Number |
K060258 |
Device Name |
AUTOFUSER |
Applicant |
ACE MEDICAL US, LLC |
9102 TURFWAY BEND DR. |
POWELL,
OH
43065 -8497
|
|
Applicant Contact |
ANDY LAMBORNE |
Correspondent |
ACE MEDICAL US, LLC |
9102 TURFWAY BEND DR. |
POWELL,
OH
43065 -8497
|
|
Correspondent Contact |
ANDY LAMBORNE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/01/2006 |
Decision Date | 05/30/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|