Device Classification Name |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
|
510(k) Number |
K222552 |
Device Name |
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) |
Applicant |
Stryker Instruments |
1941 Stryker Way |
Portage,
MI
49002
|
|
Applicant Contact |
Tu Nguyen |
Correspondent |
Stryker Instruments |
1941 Stryker Way |
Portage,
MI
49002
|
|
Correspondent Contact |
Tu Nguyen |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/23/2022 |
Decision Date | 12/09/2022 |
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
|