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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name percussor, powered-electric
510(K) Number K122111
Device Name RESPIRONICS SIMPLYCLEAR DEVICE
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
Contact colleen witt
Regulation Number868.5665
Classification Product Code
BYI  
Subsequent Product Code
NHJ  
Date Received07/17/2012
Decision Date 12/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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