MILLENIUM ANTI-SNORING DEVICE


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

Correspodent Contact nghiep v nguyen
Regulation Number 872.5570
Classification Product Code
LQZ  
Date Received 09/09/2011
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