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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 K050592
Device Name SOMNOMED MAS RXA
Applicant
SOMNOMED LTD
PO BOX 560
STILLWATER,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
SOMNOMED LTD
PO BOX 560
STILLWATER,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/08/2005
Decision Date 07/12/2005
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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