510(k) K090695

DINKLER SURGICAL SKULL CLAMP, MODEL 0308 by Dinkler Surgical Devices, Inc. — Product Code HBL

K090695 is an FDA 510(k) premarket notification submitted by Dinkler Surgical Devices, Inc. for the device "DINKLER SURGICAL SKULL CLAMP, MODEL 0308". The FDA issued a decision of Substantially Equivalent on April 23, 2009. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Dinkler Surgical Devices, Inc. has at least 1 other 510(k) clearance on record.