510(k) K862509

CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 by Lifestream Int'L, Inc. — Product Code JDY

K862509 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000". The FDA issued a decision of Substantially Equivalent on July 23, 1986. The device falls under product code JDY (Evacuator, Vapor, Cement Monomer), a Class I device regulated under 21 CFR 888.4220. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.