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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K112627
Device Name MILLENIUM ANTI-SNORING DEVICE
Applicant
MILLENIUM DENTAL LABORATORY, INC
18056 WACO DRIVE NW
RAMSEY,  MN  55303
Applicant Contact NGHIEP V NGUYEN
Correspondent
MILLENIUM DENTAL LABORATORY, INC
18056 WACO DRIVE NW
RAMSEY,  MN  55303
Correspondent Contact NGHIEP V NGUYEN
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received09/09/2011
Decision Date 06/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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