Device Classification Name |
negative pressure wound therapy powered suction pump
|
510(k) Number |
K100823 |
Device Name |
WOUND PRO APEX |
Applicant |
ACCURO MEDICAL PRODUCTS LLC |
3879 EAST 120TH AVE |
SUITE 328 |
DENVER,
CO
80233
|
|
Applicant Contact |
TODD HUBBARD |
Correspondent |
ACCURO MEDICAL PRODUCTS LLC |
3879 EAST 120TH AVE |
SUITE 328 |
DENVER,
CO
80233
|
|
Correspondent Contact |
TODD HUBBARD |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 03/24/2010 |
Decision Date | 01/24/2011 |
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
|
Recalls |
CDRH Recalls
|