510(k) K891537

CORE BIOPSY NEEDLE, CATALOG CODE #54006 by Dlp, Inc. — Product Code GDM

K891537 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "CORE BIOPSY NEEDLE, CATALOG CODE #54006". The FDA issued a decision of Substantially Equivalent on April 18, 1989. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Dlp, Inc. has at least 10 other 510(k) clearances on record.