510(k) K970152

BIOPSY TRAY by Medcare Medical Group, Inc. — Product Code FRG

K970152 is an FDA 510(k) premarket notification submitted by Medcare Medical Group, Inc. for the device "BIOPSY TRAY". The FDA issued a decision of SN on March 5, 1997. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Medcare Medical Group, Inc. has at least 7 other 510(k) clearances on record.