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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K051964
Device Name POWERNEB
Applicant
COMEDICA , INC.
2300 MCDERMOTT ROAD
SUITE 200-207
PLANO,  TX  75025
Applicant Contact KRISTA OAKES
Correspondent
COMEDICA , INC.
2300 MCDERMOTT ROAD
SUITE 200-207
PLANO,  TX  75025
Correspondent Contact KRISTA OAKES
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received07/20/2005
Decision Date 12/01/2005
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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