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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K062811
Device Name DPILOG, MODEL DPC-512
Applicant
LIFE OUTCOMES, INC.
3957 BLUE PINE CIRCLE
HIGHLANDS RANCH,  CO  80126 -8077
Applicant Contact CHARLES M HART
Correspondent
LIFE OUTCOMES, INC.
3957 BLUE PINE CIRCLE
HIGHLANDS RANCH,  CO  80126 -8077
Correspondent Contact CHARLES M HART
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/19/2006
Decision Date 12/20/2006
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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