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FDA 510(k)

Surgical Face Masks, Model: EFMDS-L50Pn BLU

K-Number: K230380 · 2023-08-03

ApplicantIris USA
Decision Date2023-08-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Masks, Model: EFMDS-L50Pn BLU is a medical device manufactured by Iris USA. It received FDA 510(k) clearance on 2023-08-03 under approval number K230380. 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 Surgical Face Masks, Model: EFMDS-L50Pn BLU?

Surgical Face Masks, Model: EFMDS-L50Pn BLU is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Iris USA. The 510(k) number is K230380.

When was Surgical Face Masks, Model: EFMDS-L50Pn BLU approved by the FDA?

Surgical Face Masks, Model: EFMDS-L50Pn BLU received FDA 510(k) clearance on 2023-08-03, under approval number K230380.

What company makes Surgical Face Masks, Model: EFMDS-L50Pn BLU?

Surgical Face Masks, Model: EFMDS-L50Pn BLU is manufactured by Iris USA.

What is the FDA product code for Surgical Face Masks, Model: EFMDS-L50Pn BLU?

The FDA product code for Surgical Face Masks, Model: EFMDS-L50Pn BLU is FXX.

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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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