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FDA 510(k)

Steiking Packaging for Medical Devices

K-Number: K210810 · 2022-01-23

ApplicantWipak OY
Decision Date2022-01-23
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steiking Packaging for Medical Devices is a medical device manufactured by Wipak OY. It received FDA 510(k) clearance on 2022-01-23 under approval number K210810. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steiking Packaging for Medical Devices?

Steiking Packaging for Medical Devices is a medical device that received FDA 510(k) clearance on 2022-01-23. It is manufactured by Wipak OY. The 510(k) number is K210810.

When was Steiking Packaging for Medical Devices approved by the FDA?

Steiking Packaging for Medical Devices received FDA 510(k) clearance on 2022-01-23, under approval number K210810.

What company makes Steiking Packaging for Medical Devices?

Steiking Packaging for Medical Devices is manufactured by Wipak OY.

What is the FDA product code for Steiking Packaging for Medical Devices?

The FDA product code for Steiking Packaging for Medical Devices is FRG.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026) PMID: 42096274 Nanoparticle-based approaches to tackling urinary tract biofilms. Nanomedicine (London, England) (2026)

Other Devices by Wipak OY

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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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