Respire Pink Series-Herbst-EF

Device, Anti-snoring

Respire Medical Holding

The following data is part of a premarket notification filed by Respire Medical Holding with the FDA for Respire Pink Series-herbst-ef.

Pre-market Notification Details

Device IDK150572
510k NumberK150572
Device Name:Respire Pink Series-Herbst-EF
ClassificationDevice, Anti-snoring
Applicant Respire Medical Holding 18 Bridge St Suite 4J Brooklyn,  NY  11201
ContactDavid Walton
CorrespondentStephen W Inglese
Quality Solutions And Support, LLC PO BOX 8271 Holland,  MI  49422
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-06
Decision Date2015-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851861007154 K150572 000
00851861007062 K150572 000
00851861007055 K150572 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.