EPIEN ROOT CANAL CLEANSER— 510(k) K123538

Substantially Equivalent

Epien Medical, Inc.

FDA 510(k) clearance K123538 for EPIEN ROOT CANAL CLEANSER, Substantially Equivalent on 2013-02-01. Applicant: Epien Medical, Inc..

Clearance details

Applicant: Epien Medical, Inc.
Product code: Code KJJ
Advisory panel: Unknown
Date received: 2012-11-16
Decision date: 2013-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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