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FDA 510(k)

ShaeferH

K-Number: K252942 · 2026-04-10

ApplicantShaeferh, LLC
Decision Date2026-04-10
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ShaeferH is a medical device manufactured by Shaeferh, LLC. It received FDA 510(k) clearance on 2026-04-10 under approval number K252942. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShaeferH?

ShaeferH is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Shaeferh, LLC. The 510(k) number is K252942.

When was ShaeferH approved by the FDA?

ShaeferH received FDA 510(k) clearance on 2026-04-10, under approval number K252942.

What company makes ShaeferH?

ShaeferH is manufactured by Shaeferh, LLC.

What is the FDA product code for ShaeferH?

The FDA product code for ShaeferH is LRK.

Related Devices (Code: LRK)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.