510(k) K000904

PENADAPT 10 by Buffalo Filter Co., Inc. — Product Code FYD

K000904 is an FDA 510(k) premarket notification submitted by Buffalo Filter Co., Inc. for the device "PENADAPT 10". The FDA issued a decision of Substantially Equivalent on June 8, 2000. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Buffalo Filter Co., Inc. has at least 10 other 510(k) clearances on record.