510(k) K953124

MAYFIELD RADIOLUCENT 2000 SKULL CLAMP by Ohio Medical Instrument Co., Inc. — Product Code HBL

K953124 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "MAYFIELD RADIOLUCENT 2000 SKULL CLAMP". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Ohio Medical Instrument Co., Inc. has at least 10 other 510(k) clearances on record.