Device Classification Name |
wound cleaner, ultrasound
|
510(k) Number |
K162721 |
Device Name |
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator |
Applicant |
ALLIQUA BIOMEDICAL, INC. |
11495 VALLEY VIEW ROAD |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
KATHY SIMPSON |
Correspondent |
ALLIQUA BIOMEDICAL, INC. |
11495 VALLEY VIEW ROAD |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
KATHY SIMPSON |
Regulation Number | 878.4410
|
Classification Product Code |
|
Date Received | 09/29/2016 |
Decision Date | 12/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|