AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)— 510(k) K112598

Name: FDA 510(k) clearance K112598
Creator: U.S. Food and Drug Administration
Published: 2013-06-20

Substantially Equivalent

American Surgical Company, LLC

FDA 510(k) clearance K112598 for AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND), Substantially Equivalent on 2013-06-20. Applicant: American Surgical Company, LLC. Device class: 2.

Clearance details

Applicant: American Surgical Company, LLC
Product code: Code HBA
Device class: Class 2
Regulation: 21 CFR 882.4700
Advisory panel: Neurology
Date received: 2011-09-07
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Lynn, MA, US

Download summary PDF View on FDA.gov ↗

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