ATG/SM-OSA APPLIANCES

Device, Jaw Repositioning

SELANE PRODUCTS, INC.

The following data is part of a premarket notification filed by Selane Products, Inc. with the FDA for Atg/sm-osa Appliances.

Pre-market Notification Details

Device IDK130130
510k NumberK130130
Device Name:ATG/SM-OSA APPLIANCES
ClassificationDevice, Jaw Repositioning
Applicant SELANE PRODUCTS, INC. 7046 OWL'S NEST TERRACE Bradenton,  FL  34203
ContactCarolyn Primus
CorrespondentCarolyn Primus
SELANE PRODUCTS, INC. 7046 OWL'S NEST TERRACE Bradenton,  FL  34203
Product CodeLQZ  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-17
Decision Date2013-08-26
Summary:summary

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