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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 K223624
Device Name Emerald Herbst
Applicant
Island Dental Lab, Inc dba Emerald Dental
76 S. Central Avenue #1D
Valley Stream,  NY  11580
Applicant Contact Israel Wettenstein
Correspondent
The EyeDeas Company
21581 Midcrest Dr.
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean, PHD
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received12/05/2022
Decision Date 05/10/2023
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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