FDA has a concern the results submitted in the 201
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Posted On: 05/05/2025 7:38:42 AM
FDA has a concern the results submitted in the 2019 clinical study in some way resulted in 3 death and or otherwise UEEC has not accounted for 4 incomplete or patient result lost to follow up. I can tell you the hemostasis application using CelluSTAT Hemostatic Gauze did not misrepresent the product or create adverse results!
Get it right FDA!
$5-$10+
Get it right FDA!
$5-$10+
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