Slow Wave DS8

Device, Jaw Repositioning

Slow Wave, Inc.

The following data is part of a premarket notification filed by Slow Wave, Inc. with the FDA for Slow Wave Ds8.

Pre-market Notification Details

Device IDK191320
510k NumberK191320
Device Name:Slow Wave DS8
ClassificationDevice, Jaw Repositioning
Applicant Slow Wave, Inc. 26100 Countryside Dr. Spicewood,  TX  78669
ContactWayne R. Wagner
CorrespondentWayne R. Wagner
Slow Wave, Inc. 26100 Countryside Dr. Spicewood,  TX  78669
Product CodeLQZ  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-15
Decision Date2020-10-02

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