510(k) K813390

BONDARY SINGLE-USE OR GOWN by The Buckeye Cellulose Corp. — Product Code FYA

K813390 is an FDA 510(k) premarket notification submitted by The Buckeye Cellulose Corp. for the device "BONDARY SINGLE-USE OR GOWN". The FDA issued a decision of Substantially Equivalent on January 5, 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.