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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 K100160
Device Name ZZOMA POSITIONAL SLEEPER MODEL 001
Applicant
Sleep Specialists, LLC
1 Congressional Dr.
Apt. C
Greenville,  DE  19807
Applicant Contact HOWARD MANN
Correspondent
Sleep Specialists, LLC
1 Congressional Dr.
Apt. C
Greenville,  DE  19807
Correspondent Contact HOWARD MANN
Regulation Number872.5570
Classification Product Code
MYB  
Date Received01/20/2010
Decision Date 05/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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