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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 K112859
Model 178G1030
Device Name ERAPID NEBULIZER SYSTEM
Original Applicant
PARI RESPIRATORY EQUIPMENT, INC.
2943 oaklake blvd.
midlothian,  VA  23112
Original Contact james l mcintire
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/30/2011
Decision Date 05/30/2012
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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