SurgiWrap FROST
K-Number: K200918 · 2021-01-07
ApplicantMast Biosurgery
Decision Date2021-01-07
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SurgiWrap FROST is a medical device manufactured by Mast Biosurgery. It received FDA 510(k) clearance on 2021-01-07 under approval number K200918. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SurgiWrap FROST?
SurgiWrap FROST is a medical device that received FDA 510(k) clearance on 2021-01-07. It is manufactured by Mast Biosurgery. The 510(k) number is K200918.
When was SurgiWrap FROST approved by the FDA?
SurgiWrap FROST received FDA 510(k) clearance on 2021-01-07, under approval number K200918.
What company makes SurgiWrap FROST?
SurgiWrap FROST is manufactured by Mast Biosurgery.
What is the FDA product code for SurgiWrap FROST?
The FDA product code for SurgiWrap FROST is FTL.
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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.