Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K171041 |
Device Name |
SilverSeal |
Applicant |
Alliqua BioMedical, Inc |
2150 Cabot Boulevard West |
Suite B |
Langhorne,
PA
19047
|
|
Applicant Contact |
Johanna Reinert |
Correspondent |
Alliqua BioMedical, Inc |
2150 Cabot Boulevard West |
Suite B |
Langhorne,
PA
19047
|
|
Correspondent Contact |
Johanna Reinert |
Classification Product Code |
|
Date Received | 04/07/2017 |
Decision Date | 08/22/2017 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|