510(k) K880431

CARETEX SURGEON'S HOODS by James River Corp. — Product Code FXY

K880431 is an FDA 510(k) premarket notification submitted by James River Corp. for the device "CARETEX SURGEON'S HOODS". The FDA issued a decision of Substantially Equivalent on February 24, 1988. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040. James River Corp. has at least 10 other 510(k) clearances on record.