Device Classification Name |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
|
510(k) Number |
K172481 |
Device Name |
IntelliCart System |
Applicant |
Dornoch Medical Systems |
200 North West Parkway |
Riverside,
MO
64150
|
|
Applicant Contact |
Larry Smith |
Correspondent |
Dornoch Medical Systems |
200 West Parkway |
Riverside,
MO
64150
|
|
Correspondent Contact |
Michael Wolford |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/16/2017 |
Decision Date | 09/14/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|