510(k) K894516

VISOSHIELD(TM), SURGICAL EYE PROTECTOR by Polamedco, Inc. — Product Code FXX

K894516 is an FDA 510(k) premarket notification submitted by Polamedco, Inc. for the device "VISOSHIELD(TM), SURGICAL EYE PROTECTOR". The FDA issued a decision of Substantially Equivalent on September 12, 1989. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Polamedco, Inc. has at least 10 other 510(k) clearances on record.