Replies to post #7388 on Arch Therapeutics Inc (ARTH)

[Amatuer17]

Did some rechecking of the listing

Product name - AC5
Classification - wound dressing, hydrogel without Drug and/or biologic

CFR21 -Regulation no -878.4022
878 - General and Plastic Surgery devices (subpart E - surgical devices)

878.4022 - Hydrogel wound dressing and burn dressing
Classification - class I - exempt from premarket authorization