MEDPOR SURGICAL GRANULE IMPLANTS— 510(k) K982040

Name: FDA 510(k) clearance K982040
Creator: U.S. Food and Drug Administration
Published: 1998-09-08

Substantially Equivalent

Porex Surgical, Inc.

FDA 510(k) clearance K982040 for MEDPOR SURGICAL GRANULE IMPLANTS, Substantially Equivalent on 1998-09-08. Applicant: Porex Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Porex Surgical, Inc.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1998-06-10
Decision date: 1998-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: College Park, GA, 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.