510(k) K200556

AquaFlate Pre-Filled Sterile Water Syringe 10mL by H R Pharmaceuticals, Inc. — Product Code EZL

K200556 is an FDA 510(k) premarket notification submitted by H R Pharmaceuticals, Inc. for the device "AquaFlate Pre-Filled Sterile Water Syringe 10mL". The FDA issued a decision of Substantially Equivalent on March 31, 2020. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. H R Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.