510(k) K962938

EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) by Excelsior Medical Corp. — Product Code FOZ

K962938 is an FDA 510(k) premarket notification submitted by Excelsior Medical Corp. for the device "EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)". The FDA issued a decision of Substantially Equivalent on October 25, 1996. 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. Excelsior Medical Corp. has at least 8 other 510(k) clearances on record.