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FDA 510(k)

StarFin

K-Number: K231407 · 2023-08-29

ApplicantPremium Medical Technology, LLC
Decision Date2023-08-29
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

StarFin is a medical device manufactured by Premium Medical Technology, LLC. It received FDA 510(k) clearance on 2023-08-29 under approval number K231407. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StarFin?

StarFin is a medical device that received FDA 510(k) clearance on 2023-08-29. It is manufactured by Premium Medical Technology, LLC. The 510(k) number is K231407.

When was StarFin approved by the FDA?

StarFin received FDA 510(k) clearance on 2023-08-29, under approval number K231407.

What company makes StarFin?

StarFin is manufactured by Premium Medical Technology, LLC.

What is the FDA product code for StarFin?

The FDA product code for StarFin is HIF.

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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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