FDA 510(k)

Initial LiSi Block

K-Number: K153130 · 2016-09-13

Decision Date2016-09-13

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Initial LiSi Block is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2016-09-13 under approval number K153130. 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 Block?

Initial LiSi Block is a medical device that received FDA 510(k) clearance on 2016-09-13. It is manufactured by GC America, Inc.. The 510(k) number is K153130.

When was Initial LiSi Block approved by the FDA?

Initial LiSi Block received FDA 510(k) clearance on 2016-09-13, under approval number K153130.

What company makes Initial LiSi Block?

Initial LiSi Block is manufactured by GC America, Inc..

What is the FDA product code for Initial LiSi Block?

The FDA product code for Initial LiSi Block is EIH.

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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.