510(k) K954752

PEDIATRIC EUROPHYLIC FOLEY CATHETER by Regulatory & Marketing Services, Inc. — Product Code EZL

K954752 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "PEDIATRIC EUROPHYLIC FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Regulatory & Marketing Services, Inc. has at least 10 other 510(k) clearances on record.