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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 K120463
Device Name MOJO, VERASEAL
Original Applicant
SLEEPNET CORPORATION
24301 woodsage drive
bonita springs,  FL  34134 2958
Original Contact paul dryden
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/15/2012
Decision Date 07/27/2012
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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