510(k) K181423

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush by Amsino International, Inc. — Product Code FRO

K181423 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSure Sterile Water, and Sterile Normal Saline for Wound Flush". The FDA issued a decision of Substantially Equivalent on September 7, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Amsino International, Inc. has at least 10 other 510(k) clearances on record.