Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K183645 |
Device Name |
Silver High Performance Dressing |
Applicant |
Advanced Medical Solutions Ltd. |
Premier Park, 33 , Winsford Industrial Estate |
Winsford,
GB
CW7 3RT
|
|
Applicant Contact |
Amy Turner |
Correspondent |
Advanced Medical Solutions Ltd. |
Premier Park, 33 , Winsford Industrial Estate |
Winsford,
GB
CW7 3RT
|
|
Correspondent Contact |
Amy Turner |
Classification Product Code |
|
Date Received | 12/26/2018 |
Decision Date | 05/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|