SaliPen— 510(k) K180838

Substantially Equivalent

Saliwell , Ltd.

FDA 510(k) clearance K180838 for SaliPen, Substantially Equivalent on 2018-11-06. Applicant: Saliwell , Ltd..

Clearance details

Applicant: Saliwell , Ltd.
Product code: Code LTF
Advisory panel: Dental
Date received: 2018-03-30
Decision date: 2018-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harutzim, IL

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