510(k) K863089

DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 by Lifestream Int'L, Inc. — Product Code GDY

K863089 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.