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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 -3515
Applicant Contact STEVEN CHERNOFF
Correspondent
SAFER SLEEP LLC
P.O. BOX 3515
REDMOND,  WA  98073 -3515
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
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