AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES— 510(k) K962807

Name: FDA 510(k) clearance K962807
Creator: U.S. Food and Drug Administration
Published: 1997-05-02

Substantially Equivalent

American Surgical Sponges

FDA 510(k) clearance K962807 for AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES, Substantially Equivalent on 1997-05-02. Applicant: American Surgical Sponges. Device class: 2.

Clearance details

Applicant: American Surgical Sponges
Product code: Code HBA
Device class: Class 2
Regulation: 21 CFR 882.4700
Advisory panel: Neurology
Date received: 1996-07-18
Decision date: 1997-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.