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FDA 510(k)

ICU Health Surgical Mask

K-Number: K203064 · 2021-03-23

ApplicantPlastikon Industries
Decision Date2021-03-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICU Health Surgical Mask is a medical device manufactured by Plastikon Industries. It received FDA 510(k) clearance on 2021-03-23 under approval number K203064. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICU Health Surgical Mask?

ICU Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-23. It is manufactured by Plastikon Industries. The 510(k) number is K203064.

When was ICU Health Surgical Mask approved by the FDA?

ICU Health Surgical Mask received FDA 510(k) clearance on 2021-03-23, under approval number K203064.

What company makes ICU Health Surgical Mask?

ICU Health Surgical Mask is manufactured by Plastikon Industries.

What is the FDA product code for ICU Health Surgical Mask?

The FDA product code for ICU Health Surgical Mask is FXX.

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Related PubMed Literature

PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Related Devices (Code: FXX)

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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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