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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 Rd.
Suite 200-207
Plano,  TX  75025
Applicant Contact KRISTA OAKES
Correspondent
Comedica , Inc.
2300 Mcdermott Rd.
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
Predetermined Change
Control Plan Authorized		 No
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