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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K130130
Device Name ATG/SM-OSA APPLIANCES
Applicant
Selane Products, Inc.
7046 Owl'S Nest Terrace
Bradenton,  FL  34203
Applicant Contact CAROLYN PRIMUS
Correspondent
Selane Products, Inc.
7046 Owl'S Nest Terrace
Bradenton,  FL  34203
Correspondent Contact CAROLYN PRIMUS
Regulation Number872.5570
Classification Product Code
LQZ  
Subsequent Product Code
LRK  
Date Received01/17/2013
Decision Date 08/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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