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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 K991948
Device Name DR. B'S MOUTHPIECE, MODEL 32129-10002
Applicant
Snore - Ezzer
1217 So. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact ROBERT A GALL
Correspondent
Snore - Ezzer
1217 So. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact ROBERT A GALL
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/09/1999
Decision Date 09/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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