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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 K121631
Device Name SIMPLE T NASAL MASK
Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville,  PA  15668
Contact michelle brinker
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/04/2012
Decision Date 10/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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