510(k) K030813

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND by Primary Care Solutions, Inc. — Product Code EZL

K030813 is an FDA 510(k) premarket notification submitted by Primary Care Solutions, Inc. for the device "PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND". The FDA issued a decision of Substantially Equivalent on May 30, 2003. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Primary Care Solutions, Inc. has at least 3 other 510(k) clearances on record.