510(k) K970893

ULTRASOUND TRANSDUCER DRAPE by Protek Medical Products, Inc. — Product Code FYA

K970893 is an FDA 510(k) premarket notification submitted by Protek Medical Products, Inc. for the device "ULTRASOUND TRANSDUCER DRAPE". The FDA issued a decision of Substantially Equivalent on October 20, 1997. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Protek Medical Products, Inc. has at least 8 other 510(k) clearances on record.