510(k) K112087

TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS by Advanced Sterilization Products — Product Code KCT

K112087 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS". The FDA issued a decision of Substantially Equivalent on October 15, 2012. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.