510(k) K950982

B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE by B. Braun of America, Inc. — Product Code FCG

K950982 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE". The FDA issued a decision of Substantially Equivalent on April 4, 1995. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.