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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 K980952
Device Name SNORE-CURE ANTI-SNORING APPLIANCE
Applicant
ORTHO-TAIN, Inc.
600 13th St., NW
Washington,  DC  20005
Applicant Contact DAVID L ROSEN
Correspondent
ORTHO-TAIN, Inc.
600 13th St., NW
Washington,  DC  20005
Correspondent Contact DAVID L ROSEN
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/13/1998
Decision Date 06/01/1998
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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