MICR02 OSA DEVICE

Device, Anti-snoring

MICRODENTAL, INC.

The following data is part of a premarket notification filed by Microdental, Inc. with the FDA for Micr02 Osa Device.

Pre-market Notification Details

Device IDK133683
510k NumberK133683
Device Name:MICR02 OSA DEVICE
ClassificationDevice, Anti-snoring
Applicant MICRODENTAL, INC. 5601 ARNOLD RD. Dublin,  CA  94568
ContactLaura Sheppard
CorrespondentLaura Sheppard
MICRODENTAL, INC. 5601 ARNOLD RD. Dublin,  CA  94568
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-02
Decision Date2014-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863039000423 K133683 000
00863039000416 K133683 000

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