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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pillow, Cervical (For Mild Sleep Apnea)
510(k) Number K040161
Device Name SONA PILLOW
Applicant
Sleep Devices, Inc.
720 W. Oak St.
Suite 210
Kissimmee,  FL  34741
Applicant Contact NAJEEB A ZUBERI
Correspondent
Sleep Devices, Inc.
720 W. Oak St.
Suite 210
Kissimmee,  FL  34741
Correspondent Contact NAJEEB A ZUBERI
Regulation Number872.5570
Classification Product Code
MYB  
Date Received01/23/2004
Decision Date 04/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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