Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K043544 |
Device Name |
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR |
Applicant |
MEDELA AG |
LAETTICHSTRASSE 7 |
BAAR, ZUG,
CH
6341
|
|
Applicant Contact |
WERNER FREI |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
STEFAN PREISS |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 12/23/2004 |
Decision Date | 01/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|