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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K061688
Device Name ANTI-SNORING / SLEEP APNEA DEVICE
Applicant
Tomed Dr. Toussaint GmbH
Lindberghstr. 3a
Bensheim,  DE D-64625
Applicant Contact WINFRIED TOUSSAINT
Correspondent
Tomed Dr. Toussaint GmbH
Lindberghstr. 3a
Bensheim,  DE D-64625
Correspondent Contact WINFRIED TOUSSAINT
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/15/2006
Decision Date 09/08/2006
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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