Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K182681 |
Device Name |
AC5 Topical Gel |
Applicant |
Arch Therapeutics, Inc. |
235 Walnut Street, Suite 6 |
Framingham,
MA
01702
|
|
Applicant Contact |
Terrence W. Norchi |
Correspondent |
Arch Therapeutics, Inc. |
235 Walnut Street, Suite 6 |
Framingham,
MA
01702
|
|
Correspondent Contact |
Terrence W. Norchi |
Classification Product Code |
|
Date Received | 09/26/2018 |
Decision Date | 12/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02704104
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|