510(k) K971483

SECURE-WRAP (TM) STERILIZATION WRAP by American Threshold Industries, Inc. — Product Code FRG

K971483 is an FDA 510(k) premarket notification submitted by American Threshold Industries, Inc. for the device "SECURE-WRAP (TM) STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on June 24, 1997. 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.