510(k) K032337

HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 by Hemedex Incorporated — Product Code GWM

K032337 is an FDA 510(k) premarket notification submitted by Hemedex Incorporated for the device "HEMEDEX CRANIAL BOLT MODELS, 3601, 3602". The FDA issued a decision of Substantially Equivalent on October 21, 2003. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Hemedex Incorporated has at least 3 other 510(k) clearances on record.