Exofin Precision Pen
K-Number: K212246 · 2021-09-09
ApplicantChemence Medical, Inc.
Decision Date2021-09-09
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Exofin Precision Pen is a medical device manufactured by Chemence Medical, Inc.. It received FDA 510(k) clearance on 2021-09-09 under approval number K212246. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Exofin Precision Pen?
Exofin Precision Pen is a medical device that received FDA 510(k) clearance on 2021-09-09. It is manufactured by Chemence Medical, Inc.. The 510(k) number is K212246.
When was Exofin Precision Pen approved by the FDA?
Exofin Precision Pen received FDA 510(k) clearance on 2021-09-09, under approval number K212246.
What company makes Exofin Precision Pen?
Exofin Precision Pen is manufactured by Chemence Medical, Inc..
What is the FDA product code for Exofin Precision Pen?
The FDA product code for Exofin Precision Pen is MPN.
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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.