510(k) K073576

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES by Harod Enterprises, Inc. — Product Code HBA

K073576 is an FDA 510(k) premarket notification submitted by Harod Enterprises, Inc. for the device "NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES". The FDA issued a decision of Substantially Equivalent on February 22, 2008. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700.