BioWave BioWraps

Electrode, Cutaneous

BioWave Corporation

The following data is part of a premarket notification filed by Biowave Corporation with the FDA for Biowave Biowraps.

Pre-market Notification Details

Device IDK203158
510k NumberK203158
Device Name:BioWave BioWraps
ClassificationElectrode, Cutaneous
Applicant BioWave Corporation 8 Knight Street, Suite 201 Norwalk,  CT  06851
ContactBradford Siff
CorrespondentDave Mcgurl
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20005
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-22
Decision Date2021-07-08

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