510(k) K953082

ILIAC CREST BONE MARROW ASPIRATION NEEDLE by Baxter Healthcare Corp — Product Code GDM

K953082 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ILIAC CREST BONE MARROW ASPIRATION NEEDLE". The FDA issued a decision of Substantially Equivalent on September 22, 1995. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.