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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K130828
Device Name K SERIES CPAP SYSTEMS
Original Applicant
CURATIVE MEDICAL INC.
6518 tamarind sky ln.
fulshear,  TX  77441
Original Contact amy mckinney
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/26/2013
Decision Date 01/13/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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