PANTINO PRO POSITINER

Device, Anti-snoring

SOMNOMED INC.

The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Pantino Pro Positiner.

Pre-market Notification Details

Device IDK102521
510k NumberK102521
Device Name:PANTINO PRO POSITINER
ClassificationDevice, Anti-snoring
Applicant SOMNOMED INC. 3537 TEASLEY LANE Denton,  TX  76210
ContactBradley Southworth
CorrespondentBradley Southworth
SOMNOMED INC. 3537 TEASLEY LANE Denton,  TX  76210
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-02
Decision Date2011-03-28
Summary:summary

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