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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 K870501
Device Name THE EQUALIZER AIRWAY DEVICE
Applicant
Sleep Renewal, Inc.
9040 Airport Blvd.
Mobile,  AL  36008
Applicant Contact NORMAN J MATAR
Correspondent
Sleep Renewal, Inc.
9040 Airport Blvd.
Mobile,  AL  36008
Correspondent Contact NORMAN J MATAR
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received02/04/1987
Decision Date 03/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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