Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K203135 |
Device Name |
Medline Vacu-line Suction Aspirator |
Applicant |
Medline Industries, Inc. |
Three Lake Drive |
Northfield,
IL
60093
|
|
Applicant Contact |
Kelsey Closen |
Correspondent |
Medline Industries, Inc. |
Three Lake Drive |
Northfield,
IL
60093
|
|
Correspondent Contact |
Kelsey Closen |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/19/2020 |
Decision Date | 05/04/2021 |
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
|