Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs— 510(k) K150428

Name: FDA 510(k) clearance K150428
Creator: U.S. Food and Drug Administration
Published: 2015-04-16

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K150428 for Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs, Substantially Equivalent on 2015-04-16. Applicant: Integra Lifesciences Corp.. Device class: 2.

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code HAE
Device class: Class 2
Regulation: 21 CFR 882.4840
Advisory panel: Neurology
Date received: 2015-02-19
Decision date: 2015-04-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, 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.