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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K050883
Device Name SAFERSLEEP SYSTEM
Applicant
Safer Sleep, LLC
P.O.Box 3515
Redmond,  WA  98073
Applicant Contact STEVEN CHERNOFF
Correspondent
Safer Sleep, LLC
P.O.Box 3515
Redmond,  WA  98073
Correspondent Contact STEVEN CHERNOFF
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/07/2005
Decision Date 11/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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