510(k) K843890

CUSTOM INSTRUMENT DRAPE by Lifestream Int'L, Inc. — Product Code HMW

K843890 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "CUSTOM INSTRUMENT DRAPE". The FDA issued a decision of Substantially Equivalent on October 26, 1984. The device falls under product code HMW (Drape, Microscope, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.