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FDA 510(k)

VersaWrap

K-Number: K240817 · 2024-06-14

Decision Date2024-06-14
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VersaWrap is a medical device manufactured by Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2024-06-14 under approval number K240817. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersaWrap?

VersaWrap is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Alafair Biosciences, Inc.. The 510(k) number is K240817.

When was VersaWrap approved by the FDA?

VersaWrap received FDA 510(k) clearance on 2024-06-14, under approval number K240817.

What company makes VersaWrap?

VersaWrap is manufactured by Alafair Biosciences, Inc..

What is the FDA product code for VersaWrap?

The FDA product code for VersaWrap is OWW.

Other Devices by Alafair Biosciences, Inc.

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Related Devices (Code: OWW)

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.