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FDA 510(k)

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing

K-Number: K172155 · 2018-04-12

ApplicantStatguard, LLC
Decision Date2018-04-12
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing is a medical device manufactured by Statguard, LLC. It received FDA 510(k) clearance on 2018-04-12 under approval number K172155. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing?

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2018-04-12. It is manufactured by Statguard, LLC. The 510(k) number is K172155.

When was StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing approved by the FDA?

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing received FDA 510(k) clearance on 2018-04-12, under approval number K172155.

What company makes StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing?

StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing is manufactured by Statguard, LLC.

What is the FDA product code for StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing?

The FDA product code for StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing is QSY.

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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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