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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Non-Life-Supporting
510(k) Number K093070
Device Name DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
Applicant
Sunrise Medical
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact BETTY LOU MILLER
Correspondent
Sunrise Medical
100 Devilbiss Dr.
Somerset,  PA  15501
Correspondent Contact BETTY LOU MILLER
Regulation Number868.5895
Classification Product Code
MNS  
Date Received09/30/2009
Decision Date 01/26/2010
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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