510(k) K060097

GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 by KLS-Martin L.P. — Product Code GZT

K060097 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00". The FDA issued a decision of Substantially Equivalent on February 27, 2006. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.