Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) Number |
K150124 |
Device Name |
Cardinal Health NPWT PRO HC |
Applicant |
CARDINAL HEALTH |
1500 S Waukegan Rd |
Waukegan,
IL
60085
|
|
Applicant Contact |
TATYANA BOGDAN |
Correspondent |
Navigant Consulting, Inc |
9001 Wesleyan Road, Suite 200 |
Indianapolis,
IN
46268
|
|
Correspondent Contact |
ALLISON SCOTT |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 01/20/2015 |
Decision Date | 09/02/2015 |
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
|