510(k) K941645

BIOPSY TRAY by Cush Medical Products — Product Code FRG

K941645 is an FDA 510(k) premarket notification submitted by Cush Medical Products for the device "BIOPSY TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 14, 1994. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Cush Medical Products has at least 10 other 510(k) clearances on record.