PacEndo EDTA— 510(k) K153528

Substantially Equivalent

Pac-Dent International, Inc.

FDA 510(k) clearance K153528 for PacEndo EDTA, Substantially Equivalent on 2016-02-01. Applicant: Pac-Dent International, Inc..

Clearance details

Applicant: Pac-Dent International, Inc.
Product code: Code KJJ
Advisory panel: Unknown
Date received: 2015-12-09
Decision date: 2016-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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