GC Acrylic Primer
K-Number: K180917 · 2018-11-20
ApplicantGC America, Inc.
Decision Date2018-11-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GC Acrylic Primer is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2018-11-20 under approval number K180917. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GC Acrylic Primer?
GC Acrylic Primer is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by GC America, Inc.. The 510(k) number is K180917.
When was GC Acrylic Primer approved by the FDA?
GC Acrylic Primer received FDA 510(k) clearance on 2018-11-20, under approval number K180917.
What company makes GC Acrylic Primer?
GC Acrylic Primer is manufactured by GC America, Inc..
What is the FDA product code for GC Acrylic Primer?
The FDA product code for GC Acrylic Primer is KLE.
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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.