510(k) K810646

OR/CS WRAP by American Threshold Industries, Inc. — Product Code FRG

K810646 is an FDA 510(k) premarket notification submitted by American Threshold Industries, Inc. for the device "OR/CS WRAP". The FDA issued a decision of Substantially Equivalent on March 20, 1981. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. American Threshold Industries, Inc. has at least 10 other 510(k) clearances on record.