510(k) K001997

WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) by White Knight Healthcare, Inc. — Product Code FXX

K001997 is an FDA 510(k) premarket notification submitted by White Knight Healthcare, Inc. for the device "WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)". The FDA issued a decision of Substantially Equivalent on April 2, 2001. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. White Knight Healthcare, Inc. has at least 7 other 510(k) clearances on record.