510(k) K140963

KIMGUARD SMART-FOLD STERILIZATION WRAP by Kimberly-Clark Corp. — Product Code FRG

K140963 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KIMGUARD SMART-FOLD STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on November 10, 2014. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.