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FDA 510(k)

HyperFil-LV

K-Number: K182296 · 2018-12-14

ApplicantParkell, Inc.
Decision Date2018-12-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HyperFil-LV is a medical device manufactured by Parkell, Inc.. It received FDA 510(k) clearance on 2018-12-14 under approval number K182296. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HyperFil-LV?

HyperFil-LV is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Parkell, Inc.. The 510(k) number is K182296.

When was HyperFil-LV approved by the FDA?

HyperFil-LV received FDA 510(k) clearance on 2018-12-14, under approval number K182296.

What company makes HyperFil-LV?

HyperFil-LV is manufactured by Parkell, Inc..

What is the FDA product code for HyperFil-LV?

The FDA product code for HyperFil-LV is EBF.

Other Devices by Parkell, Inc.

K172176Parkell Universal Adhesive K191103Parkell Desensitizer Gel K190930SmarTemp X1 K210259Parkell Self-Adhesive Cement K243254Parkell Pit and Fissure Sealant

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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.

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