510(k) K902546

THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK by Anago, Inc. — Product Code FXX

K902546 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK". The FDA issued a decision of Substantially Equivalent on September 5, 1990. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Anago, Inc. has at least 10 other 510(k) clearances on record.