510(k) K964141

GE STERILE DISPOSABLE EQUIPMENT COIL COVER by Contour Fabricators, Inc. — Product Code MOS

K964141 is an FDA 510(k) premarket notification submitted by Contour Fabricators, Inc. for the device "GE STERILE DISPOSABLE EQUIPMENT COIL COVER". The FDA issued a decision of Substantially Equivalent on January 30, 1997. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Contour Fabricators, Inc. has at least 7 other 510(k) clearances on record.