510(k) K913098

APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 by Dlp, Inc. — Product Code KNW

K913098 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501". The FDA issued a decision of Substantially Equivalent on November 5, 1991. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Dlp, Inc. has at least 10 other 510(k) clearances on record.