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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 K102521
Device Name PANTINO PRO POSITINER
Applicant
SOMNOMED INC.
3537 TEASLEY LANE
DENTON,  TX  76210
Applicant Contact BRADLEY SOUTHWORTH
Correspondent
SOMNOMED INC.
3537 TEASLEY LANE
DENTON,  TX  76210
Correspondent Contact BRADLEY SOUTHWORTH
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/02/2010
Decision Date 03/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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