510(k) K052802

MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE by Manan Medical Products, Inc. — Product Code KNW

K052802 is an FDA 510(k) premarket notification submitted by Manan Medical Products, Inc. for the device "MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on November 1, 2005. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Manan Medical Products, Inc. has at least 10 other 510(k) clearances on record.