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Amatuer17

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Amatuer17

Re: BooDog post# 7388

Wednesday, 10/18/2017 7:40:19 PM

Wednesday, October 18, 2017 7:40:19 PM

Post# of 10344
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
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