Kerecis Gingiva Graft
K-Number: K192612 · 2020-11-13
ApplicantKerecis Limited
Decision Date2020-11-13
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Kerecis Gingiva Graft is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2020-11-13 under approval number K192612. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Kerecis Gingiva Graft?
Kerecis Gingiva Graft is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Kerecis Limited. The 510(k) number is K192612.
When was Kerecis Gingiva Graft approved by the FDA?
Kerecis Gingiva Graft received FDA 510(k) clearance on 2020-11-13, under approval number K192612.
What company makes Kerecis Gingiva Graft?
Kerecis Gingiva Graft is manufactured by Kerecis Limited.
What is the FDA product code for Kerecis Gingiva Graft?
The FDA product code for Kerecis Gingiva Graft is NPL.
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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.