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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 K121692
Device Name MINIME 2 NASAL MASK
Original Applicant
SLEEPNET CORPORATION
24301 woodsage drive
bonita springs,  FL  34134 2958
Original Contact paul dryden
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/07/2012
Decision Date 11/05/2012
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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