510(k) K030853

STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI by Case Medical, Inc. — Product Code FRG

K030853 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI". The FDA issued a decision of Substantially Equivalent on March 21, 2003. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Case Medical, Inc. has at least 10 other 510(k) clearances on record.