510(k) K903709

SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH by Lifestream Int'L, Inc. — Product Code GBZ

K903709 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.