SaliPen
K-Number: K180838 · 2018-11-06
ApplicantSaliwell , Ltd.
Decision Date2018-11-06
Product CodeLTF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SaliPen is a medical device manufactured by Saliwell , Ltd.. It received FDA 510(k) clearance on 2018-11-06 under approval number K180838. The device is classified under product code LTF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SaliPen?
SaliPen is a medical device that received FDA 510(k) clearance on 2018-11-06. It is manufactured by Saliwell , Ltd.. The 510(k) number is K180838.
When was SaliPen approved by the FDA?
SaliPen received FDA 510(k) clearance on 2018-11-06, under approval number K180838.
What company makes SaliPen?
SaliPen is manufactured by Saliwell , Ltd..
What is the FDA product code for SaliPen?
The FDA product code for SaliPen is LTF.
Other Devices by Saliwell , Ltd.
Related Devices (Code: LTF)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.