510(k) K895395

V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR by Baxter Healthcare Corp — Product Code GZT

K895395 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR". The FDA issued a decision of Substantially Equivalent on Oct 19, 1989. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Baxter Healthcare Corp has 507 other 510(k) clearances on record.