PacEndo Chlorhexidine— 510(k) K160577

Name: FDA 510(k) clearance K160577
Creator: U.S. Food and Drug Administration
Published: 2016-07-25

Substantially Equivalent

Pac-Dent International, Inc.

FDA 510(k) clearance K160577 for PacEndo Chlorhexidine, Substantially Equivalent on 2016-07-25. Applicant: Pac-Dent International, Inc.. Device class: Unclassified.

Clearance details

Applicant: Pac-Dent International, Inc.
Product code: Code KJJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-03-01
Decision date: 2016-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, 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.