510(k) K821564

BOUNDARY PROCESS CHANGE by The Buckeye Cellulose Corp. — Product Code FYA

K821564 is an FDA 510(k) premarket notification submitted by The Buckeye Cellulose Corp. for the device "BOUNDARY PROCESS CHANGE". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. The Buckeye Cellulose Corp. has at least 10 other 510(k) clearances on record.