VersaWrap Nerve Protector

Cuff, Nerve

Alafair Biosciences Inc

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

Pre-market Notification Details

Device IDK201631
510k NumberK201631
Device Name:VersaWrap Nerve Protector
ClassificationCuff, Nerve
Applicant Alafair Biosciences Inc 6101 W Courtyard Drive Ste 2-225 Austin,  TX  78730
ContactAngela Mallery
CorrespondentAngela Mallery
Namsa 400 Highway 169 South, Ste 500 Minneapolis,  MN  55426
Product CodeJXI  
CFR Regulation Number882.5275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2020-09-14

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