ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM— 510(k) K140685

Name: FDA 510(k) clearance K140685
Creator: U.S. Food and Drug Administration
Published: 2014-07-02

Substantially Equivalent

Sybron Endo

FDA 510(k) clearance K140685 for ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM, Substantially Equivalent on 2014-07-02. Applicant: Sybron Endo. Device class: 1.

Clearance details

Applicant: Sybron Endo
Product code: Code NYL
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2014-03-18
Decision date: 2014-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, 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.