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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 K021569
Device Name RESTFUL NIGHTS, IST-APPLIANCE
Applicant
OTTAWA DENTAL LABORATORY
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
OTTAWA DENTAL LABORATORY
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number872.5570
Classification Product Code
LRK  
Date Received05/14/2002
Decision Date 03/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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