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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 K121170
Device Name RESIN 11
Original Applicant
RESPINNOVATION SAS
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number868.5665
Classification Product Code
BYI  
Date Received04/17/2012
Decision Date 07/13/2012
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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