510(k) K071771

INSTRUMED RETRACTORS by Instrumed International, Inc. — Product Code GZT

K071771 is an FDA 510(k) premarket notification submitted by Instrumed International, Inc. for the device "INSTRUMED RETRACTORS". The FDA issued a decision of Substantially Equivalent on August 2, 2007. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Instrumed International, Inc. has at least 6 other 510(k) clearances on record.