510(k) K161311

USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles by Strukmyer Medical, LLC — Product Code FRO

K161311 is an FDA 510(k) premarket notification submitted by Strukmyer Medical, LLC for the device "USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles". The FDA issued a decision of Substantially Equivalent on August 29, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Strukmyer Medical, LLC has at least 2 other 510(k) clearances on record.