510(k) K031748

VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES by Vitalcare Group, Inc. — Product Code EZL

K031748 is an FDA 510(k) premarket notification submitted by Vitalcare Group, Inc. for the device "VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES". The FDA issued a decision of Substantially Equivalent on Aug 27, 2003. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Vitalcare Group, Inc. has at least 7 other 510(k) clearances on record.