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FDA 510(k)

Comatryx OTC

K-Number: K232758 · 2023-12-01

ApplicantStrukmyer Medical, LLC
Decision Date2023-12-01
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Comatryx OTC is a medical device manufactured by Strukmyer Medical, LLC. It received FDA 510(k) clearance on 2023-12-01 under approval number K232758. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comatryx OTC?

Comatryx OTC is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Strukmyer Medical, LLC. The 510(k) number is K232758.

When was Comatryx OTC approved by the FDA?

Comatryx OTC received FDA 510(k) clearance on 2023-12-01, under approval number K232758.

What company makes Comatryx OTC?

Comatryx OTC is manufactured by Strukmyer Medical, LLC.

What is the FDA product code for Comatryx OTC?

The FDA product code for Comatryx OTC is KGN.

Other Devices by Strukmyer Medical, LLC

K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles

Related Devices (Code: KGN)

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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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