510(k) K771108

NEEDLE, CHIBA UNIVERSITY by Johannah Medical Services, Inc. — Product Code FCG

K771108 is an FDA 510(k) premarket notification submitted by Johannah Medical Services, Inc. for the device "NEEDLE, CHIBA UNIVERSITY". The FDA issued a decision of Substantially Equivalent on July 29, 1977. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Johannah Medical Services, Inc. has at least 3 other 510(k) clearances on record.