Device Classification Name |
pump, portable, aspiration (manual or powered)
|
510(k) Number |
K983552 |
Device Name |
BASIC, MEDIAN, DOMINANT, AND VARIO |
Applicant |
MEDELA, INC. |
4610 PRIME PKWY. |
P.O. BOX 660 |
MCHENRY,
IL
60050 -7005
|
|
Applicant Contact |
STEPHEN D SMITH |
Correspondent |
MEDELA, INC. |
4610 PRIME PKWY. |
P.O. BOX 660 |
MCHENRY,
IL
60050 -7005
|
|
Correspondent Contact |
STEPHEN D SMITH |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/09/1998 |
Decision Date | 01/07/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|