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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
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