The following data is part of a premarket notification filed by Arch Therapeutics, Inc. with the FDA for Ac5 Topical Gel.
| Device ID | K182681 |
| 510k Number | K182681 |
| Device Name: | AC5 Topical Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | Arch Therapeutics, Inc. 235 Walnut Street, Suite 6 Framingham, MA 01702 |
| Contact | Terrence W. Norchi |
| Correspondent | Terrence W. 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 | 2018-09-26 |
| Decision Date | 2018-12-14 |
| Summary: | summary |