SML-OSA2 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 Sml-osa2 Appliances.

Pre-market Notification Details

Device IDK162816
510k NumberK162816
Device Name:SML-OSA2 Appliances
ClassificationDevice, Jaw Repositioning
Applicant SELANE PRODUCTS, INC. 9129 LURLINE AVENUE Chatsworth,  CA  91311
ContactJohn Christian
CorrespondentCarolyn M. Primus
PRIMUS CONSULTING 7046 OWL'S NEST TERRACE Bradenton,  FL  34203
Product CodeLQZ  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-06
Decision Date2017-07-27
Summary:summary

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