Respire Pink AT (Hard, Hard/Soft, EF)

Device, Anti-snoring

Respire Medical Holdings

The following data is part of a premarket notification filed by Respire Medical Holdings with the FDA for Respire Pink At (hard, Hard/soft, Ef).

Pre-market Notification Details

Device IDK192127
510k NumberK192127
Device Name:Respire Pink AT (Hard, Hard/Soft, EF)
ClassificationDevice, Anti-snoring
Applicant Respire Medical Holdings 18 Bridge St. Suite 3J Brooklyn,  NY  11201
ContactMadubuike Okafor
CorrespondentMadubuike Okafor
Respire Medical Holdings 18 Bridge St. Suite 3J Brooklyn,  NY  11201
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-06
Decision Date2020-02-05

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