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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 K874416
Device Name DENTAL ANTI-SNORING DEVICE
Applicant
Ortho Publications, Inc.
P.O. Box 883
Westfield,  NJ  07091
Applicant Contact PASKOW, DDS
Correspondent
Ortho Publications, Inc.
P.O. Box 883
Westfield,  NJ  07091
Correspondent Contact PASKOW, DDS
Regulation Number872.5570
Classification Product Code
LRK  
Date Received10/28/1987
Decision Date 10/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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