510(k) K161415

SteriTite Containers System & MediTray Products by Case Medical, Inc. — Product Code FRG

K161415 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "SteriTite Containers System & MediTray Products". The FDA issued a decision of Substantially Equivalent on February 10, 2017. 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.