510(k) K811819

BOUNDARY STERILIZATION WRAP by The Buckeye Cellulose Corp. — Product Code FRG

K811819 is an FDA 510(k) premarket notification submitted by The Buckeye Cellulose Corp. for the device "BOUNDARY STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on August 4, 1981. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. The Buckeye Cellulose Corp. has at least 10 other 510(k) clearances on record.