SURGISIS NERVE CUFF— 510(k) K031069

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K031069 for SURGISIS NERVE CUFF, Substantially Equivalent on 2003-05-15. Applicant: Cook Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2003-04-04
Decision date: 2003-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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K111695 — HYBRID GRAFT2012-04-02
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Data sourced from openFDA. This site is unofficial and independent of the FDA.