510(k) K951590

ASSURE, SELF-SEALING STERILIZATION POUCH by Sultan Chemists, Inc. — Product Code KCT

K951590 is an FDA 510(k) premarket notification submitted by Sultan Chemists, Inc. for the device "ASSURE, SELF-SEALING STERILIZATION POUCH". The FDA issued a decision of Substantially Equivalent on May 17, 1995. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Sultan Chemists, Inc. has at least 10 other 510(k) clearances on record.