510(k) K010583

AMBU GEL, HYDROGEL BURN DRESSING by Ambu, Inc. — Product Code MGQ

K010583 is an FDA 510(k) premarket notification submitted by Ambu, Inc. for the device "AMBU GEL, HYDROGEL BURN DRESSING". The FDA issued a decision of Substantially Equivalent on May 25, 2001. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Ambu, Inc. has at least 10 other 510(k) clearances on record.