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FDA 510(k)

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops

K-Number: K221209 · 2023-03-08

ApplicantPadm Medical, Inc.
Decision Date2023-03-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is a medical device manufactured by Padm Medical, Inc.. It received FDA 510(k) clearance on 2023-03-08 under approval number K221209. 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 PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Padm Medical, Inc.. The 510(k) number is K221209.

When was PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops approved by the FDA?

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops received FDA 510(k) clearance on 2023-03-08, under approval number K221209.

What company makes PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is manufactured by Padm Medical, Inc..

What is the FDA product code for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops?

The FDA product code for PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops is FXX.

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Related PubMed Literature

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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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