Device Classification Name |
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
|
510(k) Number |
K161020 |
Device Name |
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack |
Applicant |
REVMEDX, INC. |
25999 SW CANYON CREEK ROAD |
SUITE C |
WILSONVILLE,
OR
97070
|
|
Applicant Contact |
AMY K. POINTER |
Correspondent |
REVMEDX, INC. |
25999 SW CANYON CREEK ROAD |
SUITE C |
WILSONVILLE,
OR
97070
|
|
Correspondent Contact |
AMY K. POINTER |
Regulation Number | 878.4452
|
Classification Product Code |
|
Date Received | 04/12/2016 |
Decision Date | 07/28/2016 |
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
|
|
|