Device Classification Name |
pump, portable, aspiration (manual or powered)
|
510(k) Number |
K051758 |
Device Name |
PENUMBRA ASPIRATION PUMP, MODEL 115V |
Applicant |
PENUMBRA, INC. |
2401 MERCED ST., SUITE 200 |
SAN LEANDRO,
CA
94577
|
|
Applicant Contact |
THERESA B BRANDNER-ALLEN |
Correspondent |
PENUMBRA, INC. |
2401 MERCED ST., SUITE 200 |
SAN LEANDRO,
CA
94577
|
|
Correspondent Contact |
THERESA B BRANDNER-ALLEN |
Regulation Number | 878.4780
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/29/2005 |
Decision Date | 08/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|