Initial LiSi Press
K-Number: K153136 · 2016-06-30
ApplicantGC America, Inc.
Decision Date2016-06-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Initial LiSi Press is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2016-06-30 under approval number K153136. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Initial LiSi Press?
Initial LiSi Press is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by GC America, Inc.. The 510(k) number is K153136.
When was Initial LiSi Press approved by the FDA?
Initial LiSi Press received FDA 510(k) clearance on 2016-06-30, under approval number K153136.
What company makes Initial LiSi Press?
Initial LiSi Press is manufactured by GC America, Inc..
What is the FDA product code for Initial LiSi Press?
The FDA product code for Initial LiSi Press is EIH.
Other Devices by GC America, Inc.
Related Devices (Code: EIH)
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.