510(k) K091890

EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT by Healthpoint, Ltd. — Product Code MED

K091890 is an FDA 510(k) premarket notification submitted by Healthpoint, Ltd. for the device "EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT". The FDA issued a decision of Substantially Equivalent on March 24, 2010. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Healthpoint, Ltd. has at least 1 other 510(k) clearance on record.