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Polyphemus

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Polyphemus

Re: StockTalk89 post# 9721

Tuesday, 08/11/2020 11:55:31 AM

Tuesday, August 11, 2020 11:55:31 AM

Post# of 10350
Hemostasis data for AC5 was established in a low flow, low pressure bleeding wound model with plain saline as a control. This data would be inadequate for an absorbable hemostat claim, both in type of wound and no use of an approved hemostat device as a control. ARTH & supporters have danced on this issue. Look at FDA 510(K) indication for use info for more definitive info.
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