VersaWrap Tendon Protector

Mesh, Surgical

Alafair Biosciences Inc

The following data is part of a premarket notification filed by Alafair Biosciences Inc with the FDA for Versawrap Tendon Protector.

Pre-market Notification Details

Device IDK200311
510k NumberK200311
Device Name:VersaWrap Tendon Protector
ClassificationMesh, Surgical
Applicant Alafair Biosciences Inc 6101 W Courtyard Drive Ste 2-225 Austin,  TX  78730
ContactBen Walthall
CorrespondentAngela Mallery
NAMSA 400 Highway 169 South, Ste 500 Minneapolis,  MN  55426
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-06
Decision Date2020-03-06

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