510(k) K823262

MODEL SP5800 #8 FRENCH INTRO. KIT by Gould, Inc. — Product Code DYB

K823262 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "MODEL SP5800 #8 FRENCH INTRO. KIT". The FDA issued a decision of Substantially Equivalent on January 18, 1983. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Gould, Inc. has at least 10 other 510(k) clearances on record.