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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 K060122
Device Name SLEEP SPLINT
Applicant
Nakagawa Dental Clinic
225 First St.
Mineola,  NY  11501
Applicant Contact MAKI SAKURABA
Correspondent
Nakagawa Dental Clinic
225 First St.
Mineola,  NY  11501
Correspondent Contact MAKI SAKURABA
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/17/2006
Decision Date 05/19/2006
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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