510(k) K974758

HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE by Hydrox Laboratories — Product Code JOL

K974758 is an FDA 510(k) premarket notification submitted by Hydrox Laboratories for the device "HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE". The FDA issued a decision of Substantially Equivalent on March 9, 1998. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Hydrox Laboratories has at least 1 other 510(k) clearance on record.