VersaWrap
K-Number: K213163 · 2021-10-29
ApplicantAlafair Biosciences, Inc.
Decision Date2021-10-29
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
VersaWrap is a medical device manufactured by Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2021-10-29 under approval number K213163. The device is classified under product code FTM. 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 2021-10-29. It is manufactured by Alafair Biosciences, Inc.. The 510(k) number is K213163.
When was VersaWrap approved by the FDA?
VersaWrap received FDA 510(k) clearance on 2021-10-29, under approval number K213163.
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 FTM.
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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.