Device Classification Name |
apparatus, suction, ward use, portable, ac-powered
|
510(k) Number |
K190789 |
Device Name |
IntelliCartTM System |
Applicant |
Dornoch Medical Systems |
200 North West Parkway |
Riverside,
MO
64150
|
|
Applicant Contact |
Larry Smith |
Correspondent |
Dornoch Medical Systems |
200 North West Parkway |
Riverside,
MO
64150
|
|
Correspondent Contact |
Michael Wolford |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 03/27/2019 |
Decision Date | 04/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|