The following data is part of a premarket notification filed by Arch Therapeutics, Inc. with the FDA for Ac5 Topical Gel.
Device ID | K190129 |
510k Number | K190129 |
Device Name: | AC5 Topical Gel |
Classification | Dressing, Wound, Drug |
Applicant | Arch Therapeutics, Inc. 235 Walnut Street, Suite 6 Framingham, MA 01702 |
Contact | Terrence Norchi |
Correspondent | Terrence Norchi Arch Therapeutics, Inc. 235 Walnut Street, Suite 6 Framingham, MA 01702 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-28 |
Decision Date | 2020-03-11 |