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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 K090911
Device Name IST SNORING APPLIANCE
Applicant
Dental Crafters
P.O. Box 770
Marshfeld,  WI  54449
Applicant Contact AMY NYSTROM
Correspondent
Dental Crafters
P.O. Box 770
Marshfeld,  WI  54449
Correspondent Contact AMY NYSTROM
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received04/01/2009
Decision Date 09/11/2009
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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