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FDA 510(k)

UltraClot, UltraClot OTC

K-Number: K082601 · 2008-10-09

ApplicantEmergency Medical Devices, LLC
Decision Date2008-10-09
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

UltraClot, UltraClot OTC is the device name listed in this FDA 510(k) record. The listed applicant is Emergency Medical Devices, LLC. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K082601. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraClot, UltraClot OTC?

UltraClot, UltraClot OTC is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Emergency Medical Devices, LLC. The 510(k) number is K082601.

When did UltraClot, UltraClot OTC receive FDA 510(k) clearance?

UltraClot, UltraClot OTC received FDA 510(k) clearance on 2008-10-09, under 510(k) number K082601.

Who is the listed applicant for UltraClot, UltraClot OTC?

The FDA 510(k) record lists Emergency Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraClot, UltraClot OTC?

The FDA product code for UltraClot, UltraClot OTC is QSY.

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Related Devices (Code: QSY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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