510(k) K854003

STERILE SOFT TISSUE BIOPSY NEEDLE by Co-Medical, Inc. — Product Code GEE

K854003 is an FDA 510(k) premarket notification submitted by Co-Medical, Inc. for the device "STERILE SOFT TISSUE BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on October 18, 1985. The device falls under product code GEE (Brush, Biopsy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Co-Medical, Inc. has at least 1 other 510(k) clearance on record.