510(k) K971076

PRIMED SHOE COVERS, PRIMED HEAD COVERS by Primeline Medical Products, Inc. — Product Code FXP

K971076 is an FDA 510(k) premarket notification submitted by Primeline Medical Products, Inc. for the device "PRIMED SHOE COVERS, PRIMED HEAD COVERS". The FDA issued a decision of Substantially Equivalent on January 13, 1998. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Primeline Medical Products, Inc. has at least 8 other 510(k) clearances on record.