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FDA 510(k)

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

K-Number: K202096 · 2021-02-02

ApplicantEcoguard, Inc.
Decision Date2021-02-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is a medical device manufactured by Ecoguard, Inc.. It received FDA 510(k) clearance on 2021-02-02 under approval number K202096. 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-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is a medical device that received FDA 510(k) clearance on 2021-02-02. It is manufactured by Ecoguard, Inc.. The 510(k) number is K202096.

When was 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On approved by the FDA?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On received FDA 510(k) clearance on 2021-02-02, under approval number K202096.

What company makes 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is manufactured by Ecoguard, Inc..

What is the FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

The FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is FXX.

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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