510(k) K032777

MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE by Nipro Medical Corp. — Product Code FOZ

K032777 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE". The FDA issued a decision of Substantially Equivalent on November 14, 2003. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.