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FDA 510(k)

3 Layer Surgical Mask (134252531)

K-Number: K231618 · 2023-07-28

ApplicantOriginal Mattress Factory, Inc.
Decision Date2023-07-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3 Layer Surgical Mask (134252531) is a medical device manufactured by Original Mattress Factory, Inc.. It received FDA 510(k) clearance on 2023-07-28 under approval number K231618. 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 3 Layer Surgical Mask (134252531)?

3 Layer Surgical Mask (134252531) is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Original Mattress Factory, Inc.. The 510(k) number is K231618.

When was 3 Layer Surgical Mask (134252531) approved by the FDA?

3 Layer Surgical Mask (134252531) received FDA 510(k) clearance on 2023-07-28, under approval number K231618.

What company makes 3 Layer Surgical Mask (134252531)?

3 Layer Surgical Mask (134252531) is manufactured by Original Mattress Factory, Inc..

What is the FDA product code for 3 Layer Surgical Mask (134252531)?

The FDA product code for 3 Layer Surgical Mask (134252531) 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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