NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES— 510(k) K073576

Name: FDA 510(k) clearance K073576
Creator: U.S. Food and Drug Administration
Published: 2008-02-22

Substantially Equivalent

Harod Enterprises, Inc.

FDA 510(k) clearance K073576 for NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES, Substantially Equivalent on 2008-02-22. Applicant: Harod Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Harod Enterprises, Inc.
Product code: Code HBA
Device class: Class 2
Regulation: 21 CFR 882.4700
Advisory panel: Neurology
Date received: 2007-12-19
Decision date: 2008-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBA

view all

K193346 — Codman Surgical Patties & Strips2020-11-20
K140369 — MEDLINE NEURO SPONGE2014-09-26
K112598 — AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)2013-06-20
K121822 — DELICOT2012-09-10
K062406 — AESCULAP NEURO PATTIES2006-09-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.