Cleared Traditional

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES

K073576 · Harod Enterprises, Inc. · Neurology

Feb 2008

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K073576 is an FDA 510(k) clearance for the NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES, a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by Harod Enterprises, Inc. (Martinez, US). The FDA issued a Cleared decision on February 22, 2008, 65 days after receiving the submission on December 19, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.

Submission Details

510(k) Number	K073576 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2007
Decision Date	February 22, 2008
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF