ENDO-CORD— 510(k) K141330

Substantially Equivalent

Enroxtech, Inc.

FDA 510(k) clearance K141330 for ENDO-CORD, Substantially Equivalent on 2014-12-15. Applicant: Enroxtech, Inc.. Device class: 2.

Clearance details

Applicant: Enroxtech, Inc.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2014-05-21
Decision date: 2014-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, 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.